Fitc Murine Monoclonal Anti-Hsv Bivalent Igg
FDA 510(k) K880996 · Whittaker Bioproducts, Inc.
510(k) numberK880996
Submission
- Device name
- Fitc Murine Monoclonal Anti-Hsv Bivalent Igg
- Applicant
- Whittaker Bioproducts, Inc.
Walkersville, MD, US - Received
- March 8, 1988
- Decision date
- May 13, 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
Other 510(k)s with product code GQN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K884761 | Modified Cell-Matics Herpes Simplex Virus Detect.GQN · Traditional | Difco Laboratories, Inc. | 12/05/1988SE |
More from Difco Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K911356 | Legionella Stat Igg/Igm Test KitMJH · Traditional | 07/30/1992SE |
| K913212 | 3M Ige Single Point Fast TestDHB · Traditional | 11/22/1991SE |
| K904652 | Lyme Stat M Test KitLSR · Traditional | 10/21/1991SE |
| K904893 | Fiax Lyme M Test KitLSR · Traditional | 10/16/1991SE |
| K911473 | Ebna Stat Test KitLLM · Traditional | 09/25/1991SE |
| K905468 | Pylori-G Fiax Test KitLYR · Traditional | 05/07/1991SE |
| K904738 | Pylori Stat Test KitLYR · Traditional | 05/07/1991SE |
| K901493 | Fitc Murine Monoclonal Anti-Influenza Type BGNX · Traditional | 06/27/1990SE |
| K893579 | Fitc Murine Monoclonal Anti-Influenza Type aGNX · Traditional | 01/16/1990SE |
| K894932 | Fiax Eb Vca-M Test KitLSE · Traditional | 10/16/1989SE |
Questions and answers
When was Fitc Murine Monoclonal Anti-Hsv Bivalent Igg cleared by the FDA?
Fitc Murine Monoclonal Anti-Hsv Bivalent Igg (K880996) received a 510(k) decision of Substantially Equivalent on May 13, 1988, 66 days after the submission was received.
What is the product code of K880996?
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.