Bactidrop Koh (10%)

FDA 510(k) K920970 · Remel Co.

Substantially Equivalent

510(k) numberK920970

Submission

Device name
Bactidrop Koh (10%)
Applicant
Remel Co.
Lenexa, KS, US
Received
March 2, 1992
Decision date
June 9, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JTS – Stains, Microbiologic
Device class
Class I (low risk)
Regulation
21 CFR 864.1850
Specialty
Hematology

Other 510(k)s with product code JTS

510(k)DeviceApplicantDecision
K960095Bactidrop Calcofluor WhiteJTS · Traditional Remel Co.03/19/1996SE
K960090Calcofluor White Stain KitJTS · Traditional Remel Co.03/19/1996SE
K920976Bactidrop India InkJTS · Traditional Remel Co.06/09/1992SE
K920975Bactidrop Calcofluor WhiteJTS · Traditional Remel Co.06/09/1992SE
K893530Iristain Formula 2, Parts 1 and 2JTS · Traditional Intl. Remote Imaging Systems06/13/1989SE
K890861Ats Dobell & O'Connor's IodineJTS · Traditional Alpha-Tec Systems, Inc.03/23/1989SE
K890020Ats Lugol's Iodine SolutionJTS · Traditional Alpha-Tec Systems, Inc.02/24/1989SE
K884069Snap N' Stain Iodine StainJTS · Traditional Scientific Device Laboratory, Inc.10/25/1988SE
K883052Metheno-Stain KitJTS · Traditional Scientific Device Laboratory, Inc.08/30/1988SE
K883061Ats Para-Set Carbol-Xylene SolutionJTS · Traditional Alpha-Tech Systems, Inc.08/17/1988SE

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Questions and answers

When was Bactidrop Koh (10%) cleared by the FDA?

Bactidrop Koh (10%) (K920970) received a 510(k) decision of Substantially Equivalent on June 9, 1992, 99 days after the submission was received.

What is the product code of K920970?

The FDA product code is JTS – Stains, Microbiologic, a Class I (low risk) device regulated under 21 CFR 864.1850.