Determin Hemoglobin Alc/Hi Perf Liq Chromatography
FDA 510(k) K882222 · Bio-Rad
510(k) numberK882222
Submission
- Device name
- Determin Hemoglobin Alc/Hi Perf Liq Chromatography
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- May 26, 1988
- Decision date
- August 1, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7470
- Specialty
- Hematology
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Questions and answers
When was Determin Hemoglobin Alc/Hi Perf Liq Chromatography cleared by the FDA?
Determin Hemoglobin Alc/Hi Perf Liq Chromatography (K882222) received a 510(k) decision of Substantially Equivalent on August 1, 1988, 67 days after the submission was received.
What is the product code of K882222?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.