NORDICLAB PROSTATIC ACID PHOSPHATASE RIA— 510(k) K801988

Name: FDA 510(k) clearance K801988
Creator: U.S. Food and Drug Administration
Published: 1980-09-26

Substantially Equivalent

Nordiclab Intl.

FDA 510(k) clearance K801988 for NORDICLAB PROSTATIC ACID PHOSPHATASE RIA, Substantially Equivalent on 1980-09-26. Applicant: Nordiclab Intl.. Device class: 2.

Clearance details

Applicant: Nordiclab Intl.
Product code: Code JFH
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1980-08-19
Decision date: 1980-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K931701 — IMMULITE PAP1994-01-27
K925377 — IMX PAP1993-01-13

More clearances from Nordiclab Intl.

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K801989 — NORDICLAB FERRITIN IRMA TEST1980-09-16
K800920 — NORDICLAB ESTRADIOL RIA TEST1980-05-14
K800921 — NORDICLAB TESTOSTERONE RIA TEST1980-05-14
K800922 — NORDICLAB PROGESTERONE RIA TEST1980-05-14
K792189 — NORDICLAB TOTAL ESTRIOL RIA TEST1979-11-13

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