PAP-CHECK RIA KIT— 510(k) K792043

Substantially Equivalent

Serono Laboratories, Inc.

FDA 510(k) clearance K792043 for PAP-CHECK RIA KIT, Substantially Equivalent on 1979-10-30. Applicant: Serono Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Serono Laboratories, Inc.
Product code: Code JFH
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1979-10-12
Decision date: 1979-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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 Serono Laboratories, Inc.

K834428 — ALDOSTERONE RADIOIMMUNOASSAY TEST KIT1984-03-02
K810695 — ESTRIOL RADIOIMMUNOASSAY TEST KIT1981-03-31
K810625 — HUMAN PLACENTAL LACTOGEN RADIOIMMUNO-1981-03-27
K790679 — ESTRADIOL RIA KIT1979-05-23
K790440 — PROGESTERONE1979-05-03

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