Hemolab Protein C Chromogenic Assay
FDA 510(k) K934210 · Biomerieux Vitek, Inc.
510(k) numberK934210
Submission
- Device name
- Hemolab Protein C Chromogenic Assay
- Applicant
- Biomerieux Vitek, Inc.
Hazelwood, MO, US - Received
- August 30, 1993
- Decision date
- December 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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| K181525 | INNOVANCE Free PS AgGGP · Traditional | Siemens Healthcare Diagnostics Products GmbH | 09/07/2018SE |
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Questions and answers
When was Hemolab Protein C Chromogenic Assay cleared by the FDA?
Hemolab Protein C Chromogenic Assay (K934210) received a 510(k) decision of Substantially Equivalent on December 22, 1994, 479 days after the submission was received.
What is the product code of K934210?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.