BACTIDROP KOH (10%)— 510(k) K920970

Substantially Equivalent

Remel Co.

FDA 510(k) clearance K920970 for BACTIDROP KOH (10%), Substantially Equivalent on 1992-06-09. 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: 1992-03-02
Decision date: 1992-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

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Recent devices under product code JTS

K960090 — CALCOFLUOR WHITE STAIN KIT1996-03-19
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K920975 — BACTIDROP CALCOFLUOR WHITE1992-06-09
K920976 — BACTIDROP INDIA INK1992-06-09
K893530 — IRISTAIN FORMULA 2, PARTS 1 AND 21989-06-13

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