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FDA 510(k)

ACP KINETIC TEST (ACID PHOSPHATASE TEST)

K-Number: K881204 · 1988-04-28

ApplicantSclavo, Inc.
Decision Date1988-04-28
Product CodeCKB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACP KINETIC TEST (ACID PHOSPHATASE TEST) is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1988-04-28 under 510(k) number K881204. 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 ACP KINETIC TEST (ACID PHOSPHATASE TEST)?

ACP KINETIC TEST (ACID PHOSPHATASE TEST) is a medical device that received FDA 510(k) clearance on 1988-04-28. The listed applicant is Sclavo, Inc.. The 510(k) number is K881204.

When did ACP KINETIC TEST (ACID PHOSPHATASE TEST) receive FDA 510(k) clearance?

ACP KINETIC TEST (ACID PHOSPHATASE TEST) received FDA 510(k) clearance on 1988-04-28, under 510(k) number K881204.

Who is the listed applicant for ACP KINETIC TEST (ACID PHOSPHATASE TEST)?

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

What is the FDA product code for ACP KINETIC TEST (ACID PHOSPHATASE TEST)?

The FDA product code for ACP KINETIC TEST (ACID PHOSPHATASE TEST) is CKB.

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Other records listing Sclavo, 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.

K914789ELISA CMV IGMK914852ELISA TOXO IGMK914420ELISA RUBELLA IGMK895943NORMAL AND ABNORMAL CONTROL SERAK895822TOTAL BILIRUBIN L.F.K895847CREATININE 340 (ENZYMATIC)

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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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