Reads Anti-Cardiolipin Semi-Quantitative Test Kit
FDA 510(k) K902236 · Biosearch Medical Products, Inc.
510(k) numberK902236
Submission
- Device name
- Reads Anti-Cardiolipin Semi-Quantitative Test Kit
- Applicant
- Biosearch Medical Products, Inc.
Boulder, CO, US - Received
- May 17, 1990
- Decision date
- August 14, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGW – Test, Time, Partial Thromboplastin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7925
- Specialty
- Hematology
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Questions and answers
When was Reads Anti-Cardiolipin Semi-Quantitative Test Kit cleared by the FDA?
Reads Anti-Cardiolipin Semi-Quantitative Test Kit (K902236) received a 510(k) decision of Substantially Equivalent on August 14, 1990, 89 days after the submission was received.
What is the product code of K902236?
The FDA product code is GGW – Test, Time, Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.