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FDA 510(k)

ACID PHOSPHATASE DIAG. KIT

K-Number: K781489 · 1978-10-03

ApplicantSclavo, Inc.
Decision Date1978-10-03
Product CodeCJN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACID PHOSPHATASE DIAG. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1978-10-03 under 510(k) number K781489. The device is classified under product code CJN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACID PHOSPHATASE DIAG. KIT?

ACID PHOSPHATASE DIAG. KIT is a medical device that received FDA 510(k) clearance on 1978-10-03. The listed applicant is Sclavo, Inc.. The 510(k) number is K781489.

When did ACID PHOSPHATASE DIAG. KIT receive FDA 510(k) clearance?

ACID PHOSPHATASE DIAG. KIT received FDA 510(k) clearance on 1978-10-03, under 510(k) number K781489.

Who is the listed applicant for ACID PHOSPHATASE DIAG. KIT?

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 ACID PHOSPHATASE DIAG. KIT?

The FDA product code for ACID PHOSPHATASE DIAG. KIT is CJN.

Related Clinical Trials

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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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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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