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FDA 510(k)

ALP TEST

K-Number: K781324 · 1978-08-31

ApplicantAnalytical & Research Chemicals, Inc.
Decision Date1978-08-31
Product CodeCIO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALP TEST is the device name listed in this FDA 510(k) record. The listed applicant is Analytical & Research Chemicals, Inc.. It received FDA 510(k) clearance on 1978-08-31 under 510(k) number K781324. The device is classified under product code CIO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALP TEST?

ALP TEST is a medical device that received FDA 510(k) clearance on 1978-08-31. The listed applicant is Analytical & Research Chemicals, Inc.. The 510(k) number is K781324.

When did ALP TEST receive FDA 510(k) clearance?

ALP TEST received FDA 510(k) clearance on 1978-08-31, under 510(k) number K781324.

Who is the listed applicant for ALP TEST?

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

What is the FDA product code for ALP TEST?

The FDA product code for ALP TEST is CIO.

Other records listing Analytical & Research Chemicals, 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.

K823784ENZYMATIC CHOLESTEROL (COLORIMETRICK823786ALKALINE PHOSPHATASEK823806DIRECT CREATININE PROCEDUREK781441BCG ALBUMIN REAGETK781460CHLORIDE REAGENTK781305UREA NITROGEN

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Related Devices (Code: CIO)

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.

K880177ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHATTech-Co, Inc.K860351ALKALINE PHOSPHATASE REAGENT SETSterling Diagnostics, Inc.K855192ALKALINE PHOSPHATASE REAGENT SETTechnostics Intl.K844498SANDARE ALKALINE PHOSPHATASE PROCEDURESandare Chemical Co., Inc.K844237ALKALINE PHOSPHATASE REAGENT SETLivonia Diagnostics, Inc.K841064ALKALINE PHOSPHOTASE REAGENT SETMedical Specialties, 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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