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FDA 510(k)

KREBS-HENSELEIT BICARBONATE BUFFER NO. K3753

K-Number: K882965 · 1988-08-04

ApplicantSigma Chemical Co.
Decision Date1988-08-04
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

KREBS-HENSELEIT BICARBONATE BUFFER NO. K3753 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 1988-08-04 under 510(k) number K882965. 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 KREBS-HENSELEIT BICARBONATE BUFFER NO. K3753?

KREBS-HENSELEIT BICARBONATE BUFFER NO. K3753 is a medical device that received FDA 510(k) clearance on 1988-08-04. The listed applicant is Sigma Chemical Co.. The 510(k) number is K882965.

When did KREBS-HENSELEIT BICARBONATE BUFFER NO. K3753 receive FDA 510(k) clearance?

KREBS-HENSELEIT BICARBONATE BUFFER NO. K3753 received FDA 510(k) clearance on 1988-08-04, under 510(k) number K882965.

Who is the listed applicant for KREBS-HENSELEIT BICARBONATE BUFFER NO. K3753?

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 KREBS-HENSELEIT BICARBONATE BUFFER NO. K3753?

The FDA product code for KREBS-HENSELEIT BICARBONATE BUFFER NO. K3753 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 REAGENTK933679SIGMA BUN REAGENTK933691SIGMA CO2 ALKALINE BUFFER 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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