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FDA 510(k)

RAICHEM ACID PHASPHATASE REAGENT

K-Number: K831834 · 1983-08-26

ApplicantReagents Applications, Inc.
Decision Date1983-08-26
Product CodeCKB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM ACID PHASPHATASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Reagents Applications, Inc.. It received FDA 510(k) clearance on 1983-08-26 under 510(k) number K831834. 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 RAICHEM ACID PHASPHATASE REAGENT?

RAICHEM ACID PHASPHATASE REAGENT is a medical device that received FDA 510(k) clearance on 1983-08-26. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K831834.

When did RAICHEM ACID PHASPHATASE REAGENT receive FDA 510(k) clearance?

RAICHEM ACID PHASPHATASE REAGENT received FDA 510(k) clearance on 1983-08-26, under 510(k) number K831834.

Who is the listed applicant for RAICHEM ACID PHASPHATASE REAGENT?

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

What is the FDA product code for RAICHEM ACID PHASPHATASE REAGENT?

The FDA product code for RAICHEM ACID PHASPHATASE REAGENT is CKB.

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Other records listing Reagents Applications, 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.

K982056RAICHEM CO2 REAGENTK972853CHOLESTEROL RAPID LIQUID REAGENTK922904RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND IIK915191RAI-TROL ELEVATED LIPIDS CONTROLK913398RAICHEM(TM) CREATINE KINASE-MB REAGENTK911900RAICHEM SPIA C3 REAGENT

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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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