FDA 510(k)

DULBECCO'S MODIFIED EAGLE #D5523-

K-Number: K832688 · 1983-09-12

Decision Date1983-09-12

Product CodeKIT

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

DULBECCO'S MODIFIED EAGLE #D5523- 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 1983-09-12 under 510(k) number K832688. 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 DULBECCO'S MODIFIED EAGLE #D5523-?

DULBECCO'S MODIFIED EAGLE #D5523- is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Sigma Chemical Co.. The 510(k) number is K832688.

When did DULBECCO'S MODIFIED EAGLE #D5523- receive FDA 510(k) clearance?

DULBECCO'S MODIFIED EAGLE #D5523- received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832688.

Who is the listed applicant for DULBECCO'S MODIFIED EAGLE #D5523-?

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 DULBECCO'S MODIFIED EAGLE #D5523-?

The FDA product code for DULBECCO'S MODIFIED EAGLE #D5523- 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.