JTL · Class I · 21 CFR 866.2160

FDA Product Code JTL: Plasma, Coagulase, Human, Horse And Rabbit

Leading manufacturers include Remel Co., Analytical Products, Inc. and American Scientific Products.

12
Total
12
Cleared
36d
Avg days
1979
Since

FDA 510(k) Cleared Plasma, Coagulase, Human, Horse And Rabbit Devices (Product Code JTL)

12 devices
1–12 of 12
Cleared May 16, 1995
DRYSLIDE COAGULASE
K950706
Difco Laboratories, Inc.
Microbiology · 90d
Cleared Aug 25, 1988
RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT
K883333
Immuno-Mycologics, Inc.
Microbiology · 16d
Cleared Jun 10, 1987
RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122
K870945
Oxoid U.S.A., Inc.
Microbiology · 93d
Cleared Apr 18, 1986
LYFO-KWIK (TM) COAGULASE PLASMA
K861312
Micro-Bio-Logics
Hematology · 10d
Cleared Apr 13, 1984
HEMASTAPH
K840553
Remel Co.
Microbiology · 65d
Cleared Dec 22, 1983
API STAPHASE III
K833988
Analytical Products, Inc.
Microbiology · 34d
Cleared Dec 08, 1983
COAGULASE PLASMA, HORSE & RABBIT EDTA
K833858
Otisville Biotech, Inc.
Microbiology · 31d
Cleared Nov 05, 1982
COAGULASE PLASMA-CITRATED & EDTA
K822988
American Scientific Products
Microbiology · 24d
Cleared Feb 05, 1982
COAGULASE PLASMA
K820177
Quadroma, Inc.
Microbiology · 14d
Cleared Sep 29, 1981
RABBIT COAGULASE PLASMA
K812602
Dutchland Laboratories, Inc.
Microbiology · 14d
Cleared Jul 28, 1981
STAPHASE*
K811982
Analytical Products, Inc.
Microbiology · 15d
Cleared Dec 07, 1979
COAGULASE PLASMA
K792235
Remel Co.
Microbiology · 31d

About Product Code JTL - Regulatory Context