ALTERNATE PROCEDURE, PHARMACIA IGE EIA— 510(k) K882616

Name: FDA 510(k) clearance K882616
Creator: U.S. Food and Drug Administration
Published: 1988-08-04

Substantially Equivalent

Pharmacia, Inc.

FDA 510(k) clearance K882616 for ALTERNATE PROCEDURE, PHARMACIA IGE EIA, Substantially Equivalent on 1988-08-04. Applicant: Pharmacia, Inc.. Device class: 2.

Clearance details

Applicant: Pharmacia, Inc.
Product code: Code JHR
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1988-06-24
Decision date: 1988-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Piscataway, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JHR

view all

K061970 — ELECSYS IGE II IMMUNOASSAY2006-08-31
K984326 — ELECYS IGE ASSAY1999-02-08
K960067 — IMMILITE TOTAL IGE1996-02-14
K931703 — IMMULITE TOTAL IGE1993-08-16
K903000 — TURBO-RAST SPECIFIC IGE ASSAY1990-07-31

More clearances from Pharmacia, Inc.

view all

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.