Ocean Scientific VDRL Test
FDA 510(k) K864731 · Ocean Scientific, Inc.
510(k) numberK864731
Submission
- Device name
- Ocean Scientific VDRL Test
- Applicant
- Ocean Scientific, Inc.
Islandia, NY, US - Received
- December 4, 1986
- Decision date
- March 10, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GMQ – Antigens, Nontreponemal, All
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3820
- Specialty
- Microbiology
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| K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGMQ · Traditional | Gold Standard Diagnostics | 11/12/2015SE |
| K000687 | The Daya Syphilis Test/The Trust Antigen TestGMQ · Traditional | Beacon Biologicals, Inc. | 06/12/2000SE |
| K993633 | Synthetic VDRL AntigenGMQ · Traditional | Centers for Disease Control and Prevention | 02/23/2000SE |
| K992124 | Avanti Polar Lipids VDRL Antigen Slide Test Kit with 10 X 0.5 ML Ampules, Avanti Polar…GMQ · Traditional | Avanti Polar Lipids, Inc. | 09/20/1999SE |
| K954994 | TrustGMQ · Traditional | Guardian Scientific, Corp. | 10/18/1996SE |
| K955136 | RPR Card Test KitGMQ · Traditional | Remel, L.P. | 07/29/1996SE |
More from Remel, L.P.
| 510(k) | Device | Decision |
|---|---|---|
| K893810 | Immuno-Wash Automated Tube WasherJQW · Traditional | 08/03/1989SE |
| K873638 | Micro-Chem AnalyzerJJQ · Traditional | 09/29/1987SE |
| K863976 | Ocean Scientific VacutestJKA · Traditional | 10/24/1986SE |
| K860987 | Mini-Chem AnalyzerJJQ · Traditional | 05/05/1986SE |
| K840340 | Chem-Stat AnalyzerJJQ · Traditional | 03/23/1984SE |
Questions and answers
When was Ocean Scientific VDRL Test cleared by the FDA?
Ocean Scientific VDRL Test (K864731) received a 510(k) decision of Substantially Equivalent on March 10, 1987, 96 days after the submission was received.
What is the product code of K864731?
The FDA product code is GMQ – Antigens, Nontreponemal, All, a Class II (moderate risk) device regulated under 21 CFR 866.3820.