Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification and Typing Kit, Model 01-090000
FDA 510(k) K070265 · Diagnostic Hybrids, Inc.
510(k) numberK070265
Submission
- Device name
- Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification and Typing Kit, Model 01-090000
- Applicant
- Diagnostic Hybrids, Inc.
Athens, OH, US - Received
- January 29, 2007
- Decision date
- October 24, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GQN – Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3305
- Specialty
- Microbiology
Other 510(k)s with product code GQN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K063798 | Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification Kit, Model 01-080000GQN · Traditional | Diagnostic Hybrids, Inc. | 09/21/2007SE |
| K991880 | Light Diagnostics Simulfluor HSV 1/2 Immunofluorecence AssayGQN · Traditional | Light Diagnostics | 11/09/1999SE |
| K971662 | Elvis HSV Id/Typing Test SystemGQN · Traditional | Diagnostic Hybrids, Inc. | 11/18/1997SE |
| K971101 | HSV-2 Antigen Control SlidesGQN · Traditional | Viral Antigens, Inc. | 07/01/1997SE |
| K964874 | HSV-1 Antigen Control SlidesGQN · Traditional | Viral Antigens, Inc. | 07/01/1997SE |
| K960578 | Elvis HSV GoldGQN · Traditional | Diagnostic Hybrids, Inc. | 09/05/1996SE |
| K941924 | Elvis HSVGQN · Traditional | Diagnostic Hybrids, Inc. | 05/01/1995SE |
| K911345 | HSV in Situ DNA Probe Hybridization Test KitGQN · Traditional | Diagnostic Hybrids, Inc. | 06/17/1991SE |
| K884761 | Modified Cell-Matics Herpes Simplex Virus Detect.GQN · Traditional | Difco Laboratories, Inc. | 12/05/1988SE |
| K883684 | Herpes Virus Control SlidesGQN · Traditional | Val Tech Diagnostics, Inc. | 09/28/1988SE |
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| 510(k) | Device | Decision |
|---|---|---|
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| K093415 | D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus Identification KitGQS · Traditional | 12/23/2009SE |
| K093233 | D3 Fastpoint L-Dfa Rsv/Mvp Identification KitOMG · Traditional | 12/04/2009SE |
| K092882 | D3 Fastpoint L-Dfa Influenza A/Influenza B Virus Identification KitGNW · Traditional | 10/21/2009SE |
| K091171 | D3 Ultra Duet Dfa Respiratory Virus Identification KitOMG · Traditional | 09/11/2009SE |
| K092300 | Modification to D3 Ultra Dfa Respiratory Virus Screening & Id KitGNW · Special | 08/28/2009SE |
| K091753 | Elvis HSV Id and D3 Typing Test SystemGQL · Traditional | 08/28/2009SE |
| K083391 | Thyroid Stimulating Immunoglobulin Reporter AssayJZO · Traditional | 05/21/2009SE |
| K090073 | D3 Dfa Metapneumovirus Identification KitOMG · Traditional | 03/06/2009SE |
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Questions and answers
When was Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification and Typing Kit, Model 01-090000 cleared by the FDA?
Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification and Typing Kit, Model 01-090000 (K070265) received a 510(k) decision of Substantially Equivalent on October 24, 2007, 268 days after the submission was received.
What is the product code of K070265?
The FDA product code is GQN – Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2, a Class II (moderate risk) device regulated under 21 CFR 866.3305.