FDA 510(k)

EPSILON HCG TEST KIT MONOCLONAL

K-Number: K842654 · 1984-10-01

Decision Date1984-10-01

Product CodeJHI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

EPSILON HCG TEST KIT MONOCLONAL is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1984-10-01 under 510(k) number K842654. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPSILON HCG TEST KIT MONOCLONAL?

EPSILON HCG TEST KIT MONOCLONAL is a medical device that received FDA 510(k) clearance on 1984-10-01. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K842654.

When did EPSILON HCG TEST KIT MONOCLONAL receive FDA 510(k) clearance?

EPSILON HCG TEST KIT MONOCLONAL received FDA 510(k) clearance on 1984-10-01, under 510(k) number K842654.

Who is the listed applicant for EPSILON HCG TEST KIT MONOCLONAL?

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

What is the FDA product code for EPSILON HCG TEST KIT MONOCLONAL?

The FDA product code for EPSILON HCG TEST KIT MONOCLONAL is JHI.

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Other records listing Beckman Instruments, Inc. as applicant

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469 K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER K981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT K981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

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Related Devices (Code: JHI)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.