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FDA 510(k)

ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR

K-Number: K870673 · 1987-03-19

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1987-03-19
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1987-03-19 under 510(k) number K870673. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR?

ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR is a medical device that received FDA 510(k) clearance on 1987-03-19. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K870673.

When did ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR receive FDA 510(k) clearance?

ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR received FDA 510(k) clearance on 1987-03-19, under 510(k) number K870673.

Who is the listed applicant for ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR?

The FDA product code for ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR is JIT.

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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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