FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT— 510(k) K884031

Name: FDA 510(k) clearance K884031
Creator: U.S. Food and Drug Administration
Published: 1988-10-06

Substantially Equivalent

Regency Biotech

FDA 510(k) clearance K884031 for FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT, Substantially Equivalent on 1988-10-06. Applicant: Regency Biotech. Device class: 1.

Clearance details

Applicant: Regency Biotech
Product code: Code KIT
Device class: Class 1
Regulation: 21 CFR 864.2220
Advisory panel: Hematology
Date received: 1988-09-23
Decision date: 1988-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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K884654 — ALPHACALF SERUM1988-11-30

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