Hemoglobin Capillary Collection System (HCCS), 1 Test, Hemoglobin Capillary Collection System (HCCS), 5 Tests, Hemoglobi
FDA 510(k) K090737 · Bio-Rad Laboratories, Inc.
510(k) numberK090737
Submission
- Device name
- Hemoglobin Capillary Collection System (HCCS), 1 Test, Hemoglobin Capillary Collection System (HCCS), 5 Tests, Hemoglobi
- Applicant
- Bio-Rad Laboratories, Inc.
Hercules, CA, US - Received
- March 20, 2009
- Decision date
- June 3, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Specialty
- Clinical Chemistry
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Questions and answers
When was Hemoglobin Capillary Collection System (HCCS), 1 Test, Hemoglobin Capillary Collection System (HCCS), 5 Tests, Hemoglobi cleared by the FDA?
Hemoglobin Capillary Collection System (HCCS), 1 Test, Hemoglobin Capillary Collection System (HCCS), 5 Tests, Hemoglobi (K090737) received a 510(k) decision of Substantially Equivalent on June 3, 2009, 75 days after the submission was received.
What is the product code of K090737?
The FDA product code is JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection, a Class II (moderate risk) device regulated under 21 CFR 862.1675.