DELFIA PROGESTERONE KIT— 510(k) K890428

Substantially Equivalent

Pharmacia, Inc.

FDA 510(k) clearance K890428 for DELFIA PROGESTERONE KIT, Substantially Equivalent on 1989-02-23. Applicant: Pharmacia, Inc.. Device class: 1.

Clearance details

Applicant: Pharmacia, Inc.
Product code: Code JLS
Device class: Class 1
Regulation: 21 CFR 862.1620
Advisory panel: Clinical Chemistry
Date received: 1989-01-26
Decision date: 1989-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Piscataway, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JLS

K040923 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA2004-07-22
K973898 — PROGESTERONE ELISA1997-11-13
K972133 — VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)1997-06-24
K971725 — OPUS PROGESTERONE1997-06-18
K964841 — ELECSYS PROGESTERONE ASSAY1997-03-24

More clearances from Pharmacia, Inc.

K974350 — ALLERGAN IMMUNO CAP M4, M8, K701998-02-09
K972364 — UNICAP PHADIATOP1997-09-04
K972068 — UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K821997-07-03
K970420 — MASTERCAP AM 5.0/MASTERCAP RM 5.01997-06-30
K964152 — UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH1997-04-23

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