JTO · Class I · 21 CFR 866.2660

FDA Product Code JTO: Discs, Strips And Reagents, Microorganism Differentiation

Leading manufacturers include Remel Co., Difco Laboratories, Inc. and Dms Laboratories.

244

Total

244

Cleared

59d

Avg days

1976

Since

FDA 510(k) Cleared Discs, Strips And Reagents, Microorganism Differentiation Devices (Product Code JTO)

244 devices

1–24 of 244

1 2 3 4

Cleared Sep 01, 2005

IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT

K050352

Ameritek Research, LLC

LYFO(TM) DIFFERENTIAL DISK-BACITRACIN

IDS RAPID CB PLUS SYSTEM

K962966

Innovative Diagnostic Systems, Inc.

Gibson Laboratories, Inc.

Microbiology · 65d

Cleared Feb 06, 1996

DRYSLIDE CARTARRHALIS

K954783

Difco Laboratories, Inc.

Microbiology · 112d

Cleared Dec 20, 1995

LYFO(TM) DIFFERIENTAL DISK-PYR

LYFO(TM) DIFFERENTIAL DISK

LYFO(TM) DIFFERENTIAL DISK-SPS

LYFO(TM) DIFFERENTIAL DISK-STERILE DISK

LYFO(TM) DIFFERENTIAL DISK-BILE

LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN

DISPENS-O-DISC(TM) NITROCEFIN

K941016

Difco Laboratories, Inc.

SERIM PYLORITEK REAGENT STRIPS

1 2 3 4

FDA Product Code JTO: Discs, Strips And Reagents, Microorganism Differentiation

FDA 510(k) Cleared Discs, Strips And Reagents, Microorganism Differentiation Devices (Product Code JTO)

About Product Code JTO - Regulatory Context

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