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FDA 510(k)

C-REACTIVE PROTEIN TEST KIT

K-Number: K822332 · 1982-08-16

ApplicantSclavo, Inc.
Decision Date1982-08-16
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

C-REACTIVE PROTEIN TEST 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 1982-08-16 under 510(k) number K822332. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-REACTIVE PROTEIN TEST KIT?

C-REACTIVE PROTEIN TEST KIT is a medical device that received FDA 510(k) clearance on 1982-08-16. The listed applicant is Sclavo, Inc.. The 510(k) number is K822332.

When did C-REACTIVE PROTEIN TEST KIT receive FDA 510(k) clearance?

C-REACTIVE PROTEIN TEST KIT received FDA 510(k) clearance on 1982-08-16, under 510(k) number K822332.

Who is the listed applicant for C-REACTIVE PROTEIN TEST 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 C-REACTIVE PROTEIN TEST KIT?

The FDA product code for C-REACTIVE PROTEIN TEST KIT is JIS.

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Other records listing Sclavo, Inc. as applicant

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Related Devices (Code: JIS)

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.

K122126DIRECT LDL/HDL CHOLESTEROL CALIBRATORRandox Laboratories LimitedK061251DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATORDade Behring, Inc.K060266DIMENSION IRON CALIBRATORDade Behring, Inc.K053104DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATORDade Behring, Inc.K032697DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)Dade Behring, Inc.K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB

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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