Gen. Diag. Chromostrate Antithrombin III Assay
FDA 510(k) K850412 · Warner-Lambert Co.
510(k) numberK850412
Submission
- Device name
- Gen. Diag. Chromostrate Antithrombin III Assay
- Applicant
- Warner-Lambert Co.
Morris Plains, NJ, US - Received
- February 4, 1985
- Decision date
- May 8, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JBQ – Antithrombin Iii Quantitation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7060
- Specialty
- Hematology
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Questions and answers
When was Gen. Diag. Chromostrate Antithrombin III Assay cleared by the FDA?
Gen. Diag. Chromostrate Antithrombin III Assay (K850412) received a 510(k) decision of Substantially Equivalent on May 8, 1985, 93 days after the submission was received.
What is the product code of K850412?
The FDA product code is JBQ – Antithrombin Iii Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7060.