FDA 510(k)

ISCOE'S MOD. DULBECCO'S MED. W/GLUTAM

K-Number: K833393 · 1983-11-03

Decision Date1983-11-03

Product CodeKIT

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

ISCOE'S MOD. DULBECCO'S MED. W/GLUTAM 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 1983-11-03 under 510(k) number K833393. 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 ISCOE'S MOD. DULBECCO'S MED. W/GLUTAM?

ISCOE'S MOD. DULBECCO'S MED. W/GLUTAM is a medical device that received FDA 510(k) clearance on 1983-11-03. The listed applicant is Sigma Chemical Co.. The 510(k) number is K833393.

When did ISCOE'S MOD. DULBECCO'S MED. W/GLUTAM receive FDA 510(k) clearance?

ISCOE'S MOD. DULBECCO'S MED. W/GLUTAM received FDA 510(k) clearance on 1983-11-03, under 510(k) number K833393.

Who is the listed applicant for ISCOE'S MOD. DULBECCO'S MED. W/GLUTAM?

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 ISCOE'S MOD. DULBECCO'S MED. W/GLUTAM?

The FDA product code for ISCOE'S MOD. DULBECCO'S MED. W/GLUTAM 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.