TINA-QUANT(R) IGM— 510(k) K862762

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K862762 for TINA-QUANT(R) IGM, Substantially Equivalent on 1986-09-08. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code DFT
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1986-07-22
Decision date: 1986-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DFT

K983132 — IGM1998-11-04
K962201 — QUANTEX IGM1996-09-25
K955797 — IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR1996-04-05
K945522 — I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS1994-12-12
K901453 — QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD1990-04-12

More clearances from Boehringer Mannheim Corp.

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.