FDA 510(k)

RPMI 1640 MEDIUM W/L-GLUTAMINE NO. R8755

K-Number: K870489 · 1987-03-30

Decision Date1987-03-30

Product CodeKIT

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

RPMI 1640 MEDIUM W/L-GLUTAMINE NO. R8755 is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1987-03-30 under 510(k) number K870489. The device is classified under product code KIT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RPMI 1640 MEDIUM W/L-GLUTAMINE NO. R8755?

RPMI 1640 MEDIUM W/L-GLUTAMINE NO. R8755 is a medical device that received FDA 510(k) clearance on 1987-03-30. The listed applicant is Sigma Chemical Co.. The 510(k) number is K870489.

When did RPMI 1640 MEDIUM W/L-GLUTAMINE NO. R8755 receive FDA 510(k) clearance?

RPMI 1640 MEDIUM W/L-GLUTAMINE NO. R8755 received FDA 510(k) clearance on 1987-03-30, under 510(k) number K870489.

Who is the listed applicant for RPMI 1640 MEDIUM W/L-GLUTAMINE NO. R8755?

The FDA 510(k) record lists Sigma Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RPMI 1640 MEDIUM W/L-GLUTAMINE NO. R8755?

The FDA product code for RPMI 1640 MEDIUM W/L-GLUTAMINE NO. R8755 is KIT.

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Other records listing Sigma Chemical Co. as applicant

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Related Devices (Code: KIT)

K892938AMNIO-GROW TMInovar Biologicals, Inc.K890700MELANOCYTE GROWTH MEDIUM (MGM)Clonetics Corp.K890701ENDOTHELIAL GROWTH MEDIUM (EGM)Clonetics Corp.K890482ABC, ABC-1X, ABC(TM)Cell Ent., Inc.K884654ALPHACALF SERUMHyclone Laboratories, Inc.K884572RPMI-1640 HYBRI-MAX, PROD. NO. R5382Sigma Chemical Co.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.