PAP RIA KIT— 510(k) K790317

Substantially Equivalent

Yang Laboratories, Inc.

FDA 510(k) clearance K790317 for PAP RIA KIT, Substantially Equivalent on 1979-05-07. Applicant: Yang Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Yang Laboratories, Inc.
Product code: Code JFH
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1979-02-15
Decision date: 1979-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JFH

K000257 — IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA62000-02-23
K981573 — UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE1998-09-15
K964756 — PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT1997-04-23
K931701 — IMMULITE PAP1994-01-27
K925377 — IMX PAP1993-01-13

More clearances from Yang Laboratories, Inc.

K821620 — (125I) HTSH RADIOIMMUNOASSAY KIT1982-06-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.