FDA 510(k)

L-15-LEIBOVITZ W/L-GLUTAMINE-L4386

K-Number: K833164 · 1983-10-27

Decision Date1983-10-27

Product CodeKIT

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

L-15-LEIBOVITZ W/L-GLUTAMINE-L4386 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 1983-10-27 under 510(k) number K833164. 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 L-15-LEIBOVITZ W/L-GLUTAMINE-L4386?

L-15-LEIBOVITZ W/L-GLUTAMINE-L4386 is a medical device that received FDA 510(k) clearance on 1983-10-27. The listed applicant is Sigma Chemical Co.. The 510(k) number is K833164.

When did L-15-LEIBOVITZ W/L-GLUTAMINE-L4386 receive FDA 510(k) clearance?

L-15-LEIBOVITZ W/L-GLUTAMINE-L4386 received FDA 510(k) clearance on 1983-10-27, under 510(k) number K833164.

Who is the listed applicant for L-15-LEIBOVITZ W/L-GLUTAMINE-L4386?

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 L-15-LEIBOVITZ W/L-GLUTAMINE-L4386?

The FDA product code for L-15-LEIBOVITZ W/L-GLUTAMINE-L4386 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.