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FDA 510(k)

ALKALINE PHOSPHATASE, LEUKOCYTE, KIT

K-Number: K896092 · 1989-11-09

ApplicantSigma Chemical Co.
Decision Date1989-11-09
Product CodeGHD
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE, LEUKOCYTE, KIT 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 1989-11-09 under 510(k) number K896092. The device is classified under product code GHD. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALKALINE PHOSPHATASE, LEUKOCYTE, KIT?

ALKALINE PHOSPHATASE, LEUKOCYTE, KIT is a medical device that received FDA 510(k) clearance on 1989-11-09. The listed applicant is Sigma Chemical Co.. The 510(k) number is K896092.

When did ALKALINE PHOSPHATASE, LEUKOCYTE, KIT receive FDA 510(k) clearance?

ALKALINE PHOSPHATASE, LEUKOCYTE, KIT received FDA 510(k) clearance on 1989-11-09, under 510(k) number K896092.

Who is the listed applicant for ALKALINE PHOSPHATASE, LEUKOCYTE, KIT?

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 ALKALINE PHOSPHATASE, LEUKOCYTE, KIT?

The FDA product code for ALKALINE PHOSPHATASE, LEUKOCYTE, KIT is GHD.

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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: GHD)

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.

K904022NITRO BLUE TETRAZOLIUM REDUCTIONSigma Chemical Co.K903995NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KITSigma Chemical Co.K811189CHEMSTRIP LBiodynamics Corp.

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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