RPMI-1640 MED. W/L-GLUTAMINE & 25MM HEPES & W/O SO— 510(k) K845013

Name: FDA 510(k) clearance K845013
Creator: U.S. Food and Drug Administration
Published: 1985-02-27

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K845013 for RPMI-1640 MED. W/L-GLUTAMINE & 25MM HEPES & W/O SO, Substantially Equivalent on 1985-02-27. Applicant: Sigma Chemical Co.. Device class: 1.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code KIT
Device class: Class 1
Regulation: 21 CFR 864.2220
Advisory panel: Hematology
Date received: 1984-12-26
Decision date: 1985-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIT

view all

K892938 — AMNIO-GROW TM1989-05-22
K890700 — MELANOCYTE GROWTH MEDIUM (MGM)1989-02-24
K890701 — ENDOTHELIAL GROWTH MEDIUM (EGM)1989-02-24
K890482 — ABC, ABC-1X, ABC(TM)1989-02-10
K884654 — ALPHACALF SERUM1988-11-30

More clearances from Sigma Chemical Co.

view all

K933694 — SIGMA GLUCOSE REAGENT1994-11-04
K933678 — SIGMA CALCIUM REAGENT1994-03-11
K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT1994-01-03
K933679 — SIGMA BUN REAGENT1993-12-17
K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT1993-12-17

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