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FDA 510(k)

SERUM PAK, HCG CONTROL

K-Number: K790129 · 1979-03-21

ApplicantMallinckrodt Critical Care
Decision Date1979-03-21
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM PAK, HCG CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1979-03-21 under 510(k) number K790129. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERUM PAK, HCG CONTROL?

SERUM PAK, HCG CONTROL is a medical device that received FDA 510(k) clearance on 1979-03-21. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K790129.

When did SERUM PAK, HCG CONTROL receive FDA 510(k) clearance?

SERUM PAK, HCG CONTROL received FDA 510(k) clearance on 1979-03-21, under 510(k) number K790129.

Who is the listed applicant for SERUM PAK, HCG CONTROL?

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

What is the FDA product code for SERUM PAK, HCG CONTROL?

The FDA product code for SERUM PAK, HCG CONTROL is JJX.

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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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