PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL— 510(k) K902220

Name: FDA 510(k) clearance K902220
Creator: U.S. Food and Drug Administration
Published: 1990-09-05

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K902220 for PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL, Substantially Equivalent on 1990-09-05. Applicant: Boehringer Mannheim Corp.. Device class: 1.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code DGR
Device class: Class 1
Regulation: 21 CFR 866.5700
Advisory panel: Immunology
Date received: 1990-05-17
Decision date: 1990-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DGR

view all

K961544 — QUALITROL IGAME CONTROLS, LEVELS 1 AND 21996-09-24
K865014 — LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II1987-01-09
K790298 — RADIOASSAY, CONTROL SERUM I, II, III1979-04-04
K781355 — ICS NORMAL CONTROL SERUM1978-08-31

More clearances from Boehringer Mannheim Corp.

view all

K984326 — ELECYS IGE ASSAY1999-02-08
K983047 — ACCU-CHEK HQ SYSTEM1999-02-05
K984419 — ELECSYS IGE CALCHECK1999-02-02
K984425 — MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR1999-01-20
K984372 — ELECSYS CALCHECK TROPONIN T1998-12-14

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