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FDA 510(k)

HUMAN PLACENTAL LACTOGEN RADIOIMMUNO-

K-Number: K810625 · 1981-03-27

ApplicantSerono Laboratories, Inc.
Decision Date1981-03-27
Product CodeDHI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- is the device name listed in this FDA 510(k) record. The listed applicant is Serono Laboratories, Inc.. It received FDA 510(k) clearance on 1981-03-27 under 510(k) number K810625. The device is classified under product code DHI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN PLACENTAL LACTOGEN RADIOIMMUNO-?

HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- is a medical device that received FDA 510(k) clearance on 1981-03-27. The listed applicant is Serono Laboratories, Inc.. The 510(k) number is K810625.

When did HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- receive FDA 510(k) clearance?

HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- received FDA 510(k) clearance on 1981-03-27, under 510(k) number K810625.

Who is the listed applicant for HUMAN PLACENTAL LACTOGEN RADIOIMMUNO-?

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

What is the FDA product code for HUMAN PLACENTAL LACTOGEN RADIOIMMUNO-?

The FDA product code for HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- is DHI.

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Other records listing Serono Laboratories, Inc. as applicant

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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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