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FDA 510(k)

DATA ZYME ACID PHOSPHATASE PROCEDURE

K-Number: K850902 · 1985-03-20

ApplicantData Medical Associates, Inc.
Decision Date1985-03-20
Product CodeCKB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DATA ZYME ACID PHOSPHATASE PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1985-03-20 under 510(k) number K850902. 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 DATA ZYME ACID PHOSPHATASE PROCEDURE?

DATA ZYME ACID PHOSPHATASE PROCEDURE is a medical device that received FDA 510(k) clearance on 1985-03-20. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K850902.

When did DATA ZYME ACID PHOSPHATASE PROCEDURE receive FDA 510(k) clearance?

DATA ZYME ACID PHOSPHATASE PROCEDURE received FDA 510(k) clearance on 1985-03-20, under 510(k) number K850902.

Who is the listed applicant for DATA ZYME ACID PHOSPHATASE PROCEDURE?

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

What is the FDA product code for DATA ZYME ACID PHOSPHATASE PROCEDURE?

The FDA product code for DATA ZYME ACID PHOSPHATASE PROCEDURE is CKB.

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Other records listing Data Medical Associates, 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.

K993098HDL-C/LDL-C CALIBRATOR, MODEL 1913-003K971113DMA TRIGLYCERIDES PROCEDURESK961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREK955302SERUM BICARBONATE/CARBON DIOXIDEK955796IRON CALIBRATOR & CALIBRATION VERIFICATION SETK955300TOTAL BILIRUBIN PROCEDURE

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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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