Modified Cell-Matics Herpes Simplex Virus Detect.
FDA 510(k) K884761 · Difco Laboratories, Inc.
510(k) numberK884761
Submission
- Device name
- Modified Cell-Matics Herpes Simplex Virus Detect.
- Applicant
- Difco Laboratories, Inc.
Detroit, MI, US - Received
- November 14, 1988
- Decision date
- December 5, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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|---|---|---|---|
| K070265 | Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification and Typing Kit, Model…GQN · Traditional | Diagnostic Hybrids, Inc. | 10/24/2007SE |
| 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 |
| K883684 | Herpes Virus Control SlidesGQN · Traditional | Val Tech Diagnostics, Inc. | 09/28/1988SE |
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| K954783 | Dryslide CartarrhalisJTO · Traditional | 02/06/1996SE |
| K954784 | Dryside NeisseriaLTS · Traditional | 01/30/1996SE |
| K953129 | Esp Culture System - MycoMDB · Traditional | 12/26/1995SE |
| K950706 | Dryslide CoagulaseJTL · Traditional | 05/16/1995SE |
| K944275 | Dispens-O-Disc Piperacillin 100 Mcg./Tazobactam 10 Mcg.JTN · Traditional | 12/19/1994SE |
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Questions and answers
When was Modified Cell-Matics Herpes Simplex Virus Detect. cleared by the FDA?
Modified Cell-Matics Herpes Simplex Virus Detect. (K884761) received a 510(k) decision of Substantially Equivalent on December 5, 1988, 21 days after the submission was received.
What is the product code of K884761?
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.