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FDA 510(k)

SFRE199-1 MEDIUM PRODUCT NO. S 2013

K-Number: K851608 · 1985-05-15

ApplicantSigma Chemical Co.
Decision Date1985-05-15
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SFRE199-1 MEDIUM PRODUCT NO. S 2013 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 1985-05-15 under 510(k) number K851608. 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 SFRE199-1 MEDIUM PRODUCT NO. S 2013?

SFRE199-1 MEDIUM PRODUCT NO. S 2013 is a medical device that received FDA 510(k) clearance on 1985-05-15. The listed applicant is Sigma Chemical Co.. The 510(k) number is K851608.

When did SFRE199-1 MEDIUM PRODUCT NO. S 2013 receive FDA 510(k) clearance?

SFRE199-1 MEDIUM PRODUCT NO. S 2013 received FDA 510(k) clearance on 1985-05-15, under 510(k) number K851608.

Who is the listed applicant for SFRE199-1 MEDIUM PRODUCT NO. S 2013?

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 SFRE199-1 MEDIUM PRODUCT NO. S 2013?

The FDA product code for SFRE199-1 MEDIUM PRODUCT NO. S 2013 is KIT.

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Other records listing Sigma Chemical Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K933694SIGMA GLUCOSE REAGENTK933678SIGMA CALCIUM REAGENTK933696SIGMA ELECTROLYTE REFERENCE REAGENTK933691SIGMA CO2 ALKALINE BUFFER REAGENTK933679SIGMA BUN REAGENTK933703SIGMA WASH CONCENTRATE SOLUTION

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Related Devices (Code: KIT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.

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