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FDA 510(k)

ACID PHOSPHATASE (KINETIC) CAT. # 320-06

K-Number: K875209 · 1988-02-01

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1988-02-01
Product CodeCKB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACID PHOSPHATASE (KINETIC) CAT. # 320-06 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 1988-02-01 under 510(k) number K875209. The device is classified under product code CKB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACID PHOSPHATASE (KINETIC) CAT. # 320-06?

ACID PHOSPHATASE (KINETIC) CAT. # 320-06 is a medical device that received FDA 510(k) clearance on 1988-02-01. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K875209.

When did ACID PHOSPHATASE (KINETIC) CAT. # 320-06 receive FDA 510(k) clearance?

ACID PHOSPHATASE (KINETIC) CAT. # 320-06 received FDA 510(k) clearance on 1988-02-01, under 510(k) number K875209.

Who is the listed applicant for ACID PHOSPHATASE (KINETIC) CAT. # 320-06?

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 ACID PHOSPHATASE (KINETIC) CAT. # 320-06?

The FDA product code for ACID PHOSPHATASE (KINETIC) CAT. # 320-06 is CKB.

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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: CKB)

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.

K053612DRI-STAT ACID PHOSPHATASE REAGENTBeckman Coulter, Inc.K023840ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650Bayer Diagnostics Corp.K991010ACPAbbott Diagnostics Mfg., Inc.K981743OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZEROlympus America, Inc.K974695COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL)Roche Diagnostic Systems, Inc.K963640OLYMPUS ACID PHOSPHATASE REAGENTOlympus America, Inc.

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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