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FDA 510(k)

ALKALINE PHOSPHATASE CAT. # 306-22, 306-23

K-Number: K875210 · 1988-02-02

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1988-02-02
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE CAT. # 306-22, 306-23 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1988-02-02 under 510(k) number K875210. 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 ALKALINE PHOSPHATASE CAT. # 306-22, 306-23?

ALKALINE PHOSPHATASE CAT. # 306-22, 306-23 is a medical device that received FDA 510(k) clearance on 1988-02-02. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K875210.

When did ALKALINE PHOSPHATASE CAT. # 306-22, 306-23 receive FDA 510(k) clearance?

ALKALINE PHOSPHATASE CAT. # 306-22, 306-23 received FDA 510(k) clearance on 1988-02-02, under 510(k) number K875210.

Who is the listed applicant for ALKALINE PHOSPHATASE CAT. # 306-22, 306-23?

The FDA 510(k) record lists Diagnostic Chemicals, Ltd. (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALKALINE PHOSPHATASE CAT. # 306-22, 306-23?

The FDA product code for ALKALINE PHOSPHATASE CAT. # 306-22, 306-23 is CJE.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) 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.

K022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25K974874BILIRUBIN-SL (TOTAL) ASSAYK932556AMMONIA ASSAY CAT. NO. 200-02K932766HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)K932555DC-LINEATE CAT. NO. SE-091K925877DC-UIBC-CAL

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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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