HEMOGLOBIN REAGENT— 510(k) K823060

Substantially Equivalent

Biorent Diagnostic, Inc.

FDA 510(k) clearance K823060 for HEMOGLOBIN REAGENT, Substantially Equivalent on 1982-11-22. Applicant: Biorent Diagnostic, Inc.. Device class: 2.

Clearance details

Applicant: Biorent Diagnostic, Inc.
Product code: Code KHG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1982-10-18
Decision date: 1982-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Biorent Diagnostic, Inc.

K832747 — ALBUMIN REAGENT SET1983-10-14
K823211 — CK-UV REAGENT1982-11-22
K822493 — OPTIMIZED UV-GOT REAGENT SET1982-09-21
K822494 — OPTIMIZED UV-GPT REAGENT SET1982-09-21
K822492 — OPTIMIZED UV-LDH REAGENT SET1982-09-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.