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FDA 510(k)

ACID PHOSPHATASE REAGENT SET

K-Number: K902495 · 1990-07-16

ApplicantTech Intl. Co.
Decision Date1990-07-16
Product CodeCKB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACID PHOSPHATASE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Tech Intl. Co.. It received FDA 510(k) clearance on 1990-07-16 under 510(k) number K902495. 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 REAGENT SET?

ACID PHOSPHATASE REAGENT SET is a medical device that received FDA 510(k) clearance on 1990-07-16. The listed applicant is Tech Intl. Co.. The 510(k) number is K902495.

When did ACID PHOSPHATASE REAGENT SET receive FDA 510(k) clearance?

ACID PHOSPHATASE REAGENT SET received FDA 510(k) clearance on 1990-07-16, under 510(k) number K902495.

Who is the listed applicant for ACID PHOSPHATASE REAGENT SET?

The FDA 510(k) record lists Tech Intl. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACID PHOSPHATASE REAGENT SET?

The FDA product code for ACID PHOSPHATASE REAGENT SET is CKB.

Related Clinical Trials

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.

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Other records listing Tech Intl. 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.

K915704AMYLASE (KINETIC) REAGENT SETK915705ACID PHOSPHATASE REAGENT SETK915707AMMONIA REAGENT SETK914158URIC ACID REAGENT SETK915706LIPASE REAGENT SETK914160CHOLESTEROL REGEANT SET

View all 13 devices →

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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