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FDA 510(k)

DADE ESR KIT

K-Number: K823368 · 1982-12-28

ApplicantAmerican Dade
Decision Date1982-12-28
Product CodeJPH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DADE ESR KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1982-12-28 under 510(k) number K823368. The device is classified under product code JPH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DADE ESR KIT?

DADE ESR KIT is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is American Dade. The 510(k) number is K823368.

When did DADE ESR KIT receive FDA 510(k) clearance?

DADE ESR KIT received FDA 510(k) clearance on 1982-12-28, under 510(k) number K823368.

Who is the listed applicant for DADE ESR KIT?

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

What is the FDA product code for DADE ESR KIT?

The FDA product code for DADE ESR KIT is JPH.

Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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Related Devices (Code: JPH)

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.

K871076WINPETTEUlster Scientific, Inc.K860899DISPETTE IIUlster Scientific, Inc.K852554SRT-SYSTEMMicrowave Development, Inc.K840500SEDIPLASTPrecision Technology, Inc.K831195WESTERGREN DISPETTE FOR ESRUlster Scientific, Inc.K823761ERYTHROCYTE & STAND SEDIMENT. RATE TUBECordis Corp.

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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