J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA— 510(k) K801282

Name: FDA 510(k) clearance K801282
Creator: U.S. Food and Drug Administration
Published: 1980-06-30

Substantially Equivalent

J.T. Baker Chemical Co.

FDA 510(k) clearance K801282 for J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA, Substantially Equivalent on 1980-06-30. Applicant: J.T. Baker Chemical Co.. Device class: 2.

Clearance details

Applicant: J.T. Baker Chemical Co.
Product code: Code DFT
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1980-05-29
Decision date: 1980-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DFT

view all

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 J.T. Baker Chemical Co.

view all

K803128 — SERIES 810 PLATELET ANALYZER1981-04-03
K802080 — BAKER DIAG. ULTRARATE CHLORIDE KIT1980-10-10
K801909 — LSA 290 ASSAY REAGENTS/NEPHELOMETRIC1980-09-26
K802035 — BAKER DIAG. ULTRARATE CO2 REAGENT KIT1980-09-26
K801661 — J.T. BAKER CERULOPLASMIN NEPHELOMETRIC1980-09-16

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