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FDA 510(k)

URINE PREGNANCY TEST STANDARD/CONTR. PK

K-Number: K811150 · 1981-05-15

ApplicantMallinckrodt Critical Care
Decision Date1981-05-15
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URINE PREGNANCY TEST STANDARD/CONTR. PK 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 1981-05-15 under 510(k) number K811150. 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 URINE PREGNANCY TEST STANDARD/CONTR. PK?

URINE PREGNANCY TEST STANDARD/CONTR. PK is a medical device that received FDA 510(k) clearance on 1981-05-15. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K811150.

When did URINE PREGNANCY TEST STANDARD/CONTR. PK receive FDA 510(k) clearance?

URINE PREGNANCY TEST STANDARD/CONTR. PK received FDA 510(k) clearance on 1981-05-15, under 510(k) number K811150.

Who is the listed applicant for URINE PREGNANCY TEST STANDARD/CONTR. PK?

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 URINE PREGNANCY TEST STANDARD/CONTR. PK?

The FDA product code for URINE PREGNANCY TEST STANDARD/CONTR. PK is JJX.

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Other records listing Mallinckrodt Critical Care 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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