BACTIDROP CALCOFLUOR WHITE— 510(k) K960095

Substantially Equivalent

Remel Co.

FDA 510(k) clearance K960095 for BACTIDROP CALCOFLUOR WHITE, Substantially Equivalent on 1996-03-19. Applicant: Remel Co.. Device class: 1.

Clearance details

Applicant: Remel Co.
Product code: Code JTS
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1996-01-11
Decision date: 1996-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JTS

K960090 — CALCOFLUOR WHITE STAIN KIT1996-03-19
K920970 — BACTIDROP KOH (10%)1992-06-09
K920975 — BACTIDROP CALCOFLUOR WHITE1992-06-09
K920976 — BACTIDROP INDIA INK1992-06-09
K893530 — IRISTAIN FORMULA 2, PARTS 1 AND 21989-06-13

More clearances from Remel Co.

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