VDRL Carbon Antigen
FDA 510(k) K812894 · Oxoid U.S.A., Inc.
510(k) numberK812894
Submission
- Device name
- VDRL Carbon Antigen
- Applicant
- Oxoid U.S.A., Inc.
Mchenry, IL, US - Received
- October 15, 1981
- Decision date
- November 6, 1981
- 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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| K874303 | Staphylase TestLHT · Traditional | 11/06/1987SE |
| K872956 | Sorbitol Macconkey Agar No. 3 CM 813JSI · Traditional | 08/10/1987SE |
| K872135 | Mcbride Medium CM 819JSJ · Traditional | 06/15/1987SE |
| K870945 | Rabbit Plasma Fibrinogen Supplement SR 122JTL · Traditional | 06/10/1987SE |
| K862946 | Oxoid Signal Blood Culture SystemJSG · Traditional | 11/05/1986SE |
| K855236 | Diagnostic Reagent Tst-RplaGTN · Traditional | 11/04/1986SE |
| K855235 | Diagnostic Reagent Pet-RplaJSP · Traditional | 11/04/1986SE |
Questions and answers
When was VDRL Carbon Antigen cleared by the FDA?
VDRL Carbon Antigen (K812894) received a 510(k) decision of Substantially Equivalent on November 6, 1981, 22 days after the submission was received.
What is the product code of K812894?
The FDA product code is GMQ – Antigens, Nontreponemal, All, a Class II (moderate risk) device regulated under 21 CFR 866.3820.