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FDA 510(k)

ACID PHOSPHATASE REAGENT SET

K-Number: K860476 · 1986-03-05

ApplicantSterling Diagnostics, Inc.
Decision Date1986-03-05
Product CodeCKE
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 Sterling Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-03-05 under 510(k) number K860476. The device is classified under product code CKE. 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 1986-03-05. The listed applicant is Sterling Diagnostics, Inc.. The 510(k) number is K860476.

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

ACID PHOSPHATASE REAGENT SET received FDA 510(k) clearance on 1986-03-05, under 510(k) number K860476.

Who is the listed applicant for ACID PHOSPHATASE REAGENT SET?

The FDA 510(k) record lists Sterling Diagnostics, Inc. 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 CKE.

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Other records listing Sterling Diagnostics, 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.

K921412MICROPROTEIN REAGENT SETK914609TRIGLYCERIDES REAGENT SETK914039SODIUM REAGENT SETK914040PHOSPHOLIPID REAGENT SETK862255LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)K861962VANILMANDELIC ACID (VMA) REAGENT SET

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Related Devices (Code: CKE)

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.

K914167CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASEEastman Kodak CompanyK915705ACID PHOSPHATASE REAGENT SETTech Intl. Co.K873726ACID PHOSPHATASE TESTKing Diagnostics, Inc.K864230DIMENSION (TM) CLINICAL CHEMISTRY SYSTEME.I. Dupont DE Nemours & Co., Inc.K843380ACID PHOSPHATASE ASSAY KITDiagnostic Chemicals, Ltd. (Usa)K821526ACID PHOSPHATASE REAGENT SETAnco Medical Reagents & Assoc.

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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