Bioclot la
FDA 510(k) K932463 · Biopool AB
510(k) numberK932463
Submission
- Device name
- Bioclot la
- Applicant
- Biopool AB
Ontario, L7l 6b8, CA - Received
- May 21, 1993
- Decision date
- September 27, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GIR – Reagent, Russel Viper Venom
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.8950
- Specialty
- Hematology
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Questions and answers
When was Bioclot la cleared by the FDA?
Bioclot la (K932463) received a 510(k) decision of Substantially Equivalent on September 27, 1993, 129 days after the submission was received.
What is the product code of K932463?
The FDA product code is GIR – Reagent, Russel Viper Venom, a Class I (low risk) device regulated under 21 CFR 864.8950.