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FDA 510(k)

MULTICHEM ALKALINE PHOSPHATASE (S0903)

K-Number: K873761 · 1987-10-07

ApplicantSimmler, Inc.
Decision Date1987-10-07
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MULTICHEM ALKALINE PHOSPHATASE (S0903) is the device name listed in this FDA 510(k) record. The listed applicant is Simmler, Inc.. It received FDA 510(k) clearance on 1987-10-07 under 510(k) number K873761. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTICHEM ALKALINE PHOSPHATASE (S0903)?

MULTICHEM ALKALINE PHOSPHATASE (S0903) is a medical device that received FDA 510(k) clearance on 1987-10-07. The listed applicant is Simmler, Inc.. The 510(k) number is K873761.

When did MULTICHEM ALKALINE PHOSPHATASE (S0903) receive FDA 510(k) clearance?

MULTICHEM ALKALINE PHOSPHATASE (S0903) received FDA 510(k) clearance on 1987-10-07, under 510(k) number K873761.

Who is the listed applicant for MULTICHEM ALKALINE PHOSPHATASE (S0903)?

The FDA 510(k) record lists Simmler, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTICHEM ALKALINE PHOSPHATASE (S0903)?

The FDA product code for MULTICHEM ALKALINE PHOSPHATASE (S0903) is CJE.

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Other records listing Simmler, Inc. 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.

K895745SICKLE CELL SOLUBILITY TEST KITK874903MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)K874595MULTICHEM (R) MAGNESIUM REAGENTK874820MULTICHEM HDL PRECIPITATING REAGENT #S0914K874812MULTICHEM CHLORIDE REAGENT S0933K874311MULTICHEM (R) TOTAL BILIRUBIN

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Related Devices (Code: CJE)

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.

K251074Tru Liver Health Test PanelTruvian HealthK240468Alkaline PhosphataseAbbott Laboratories Diagnostics DivisionK223317Alkaline Phosphatase2Abbott Ireland Diagnostics DivisionK191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHORIBA ABX SASK171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry AnalyzerLite-On Technology Corp. H.S.P.B.K171080ALP IFCC Gen.2Roche Diagnostics Operations (Rdo)

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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