JTS · Class I · 21 CFR 864.1850

FDA Product Code JTS: Stains, Microbiologic

Leading manufacturers include Remel Co., Marion Laboratories, Inc. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

Total

Cleared

39d

Avg days

1978

Since

FDA 510(k) Cleared Stains, Microbiologic Devices (Product Code JTS)

40 devices

1–24 of 40

Cleared Mar 19, 1996

CALCOFLUOR WHITE STAIN KIT

BACTIDROP CALCOFLUOR WHITE

BACTIDROP CALCOFLUOR WHITE

CALCOFLUOR WHITE STAIN KIT

GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR

K873413

Lakewood Biochemical Co., Inc.

TB KINYOUN CARBOLFUCHSIN

SPOTTEST FLAGELLA STAIN

K871606

Difco Laboratories, Inc.

Pathology · 21d

Cleared Apr 29, 1987

TOMTEC GRAM STAINER CRYSTAL VIOLET

Sigma Diagnostics, Inc.

Pathology · 32d

Cleared Dec 22, 1981

GRAM STAIN REAGENTS AND KIT

K813369

Bd Becton Dickinson Vacutainer Systems Preanalytic

Hematology · 22d

Cleared Aug 14, 1978

DROPPERS, SOLUTION, IODINE

K781061

Marion Laboratories, Inc.

Marion Laboratories, Inc.

Immunology · 21d

FDA Product Code JTS: Stains, Microbiologic

FDA 510(k) Cleared Stains, Microbiologic Devices (Product Code JTS)

About Product Code JTS - Regulatory Context

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