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FDA 510(k)

SPINCHEM ACID PHOSPHATASE REAGENT

K-Number: K821674 · 1982-06-22

ApplicantSmithkline Diagnostics, Inc.
Decision Date1982-06-22
Product CodeCKB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPINCHEM ACID PHOSPHATASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1982-06-22 under 510(k) number K821674. 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 SPINCHEM ACID PHOSPHATASE REAGENT?

SPINCHEM ACID PHOSPHATASE REAGENT is a medical device that received FDA 510(k) clearance on 1982-06-22. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K821674.

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

SPINCHEM ACID PHOSPHATASE REAGENT received FDA 510(k) clearance on 1982-06-22, under 510(k) number K821674.

Who is the listed applicant for SPINCHEM ACID PHOSPHATASE REAGENT?

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

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

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

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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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