Device Atlas

Stains, Counterstains & Gen. Purpose

Q: What is the product code of K792483?

The FDA product code is ICL – Carbol Fuchsin, a Class I (low risk) device regulated under 21 CFR 864.1850.

FDA 510(k) K792483 · Laboratory Products, Inc.

Substantially Equivalent

510(k) numberK792483

Submission

Device name: Stains, Counterstains & Gen. Purpose
Applicant: Laboratory Products, Inc.
Mchenry, IL, US
Received: November 19, 1979
Decision date: December 18, 1979
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: ICL – Carbol Fuchsin
Device class: Class I (low risk)
Regulation: 21 CFR 864.1850
Specialty: Hematology

Other 510(k)s with product code ICL

510(k)	Device	Applicant	Decision
K890148	Ats TB Rapid Stain Set Product #034-45ICL · Traditional	Alpha-Tec Systems, Inc.	01/24/1989SE
K842933	Carbol-Fuchsin, Ziehl-NeedsenICL · Traditional	E K Ind., Inc.	09/11/1984SE
K771390	Histochemical Afb DemonstrationICL · Traditional	Harleco	08/22/1977SE

More from Harleco

510(k)	Device	Decision
K832588	Cin AgarJSJ · Traditional	09/12/1983SE
K803051	Flame Photometry ReagentsJIX · Traditional	01/09/1981SE
K803013	CHLORIDE/TCO2 Analyzer ReagentsCHJ · Traditional	01/02/1981SE
K803050	Spray, Synthetic SmearIFI · Traditional	12/30/1980SE
K800180	Various Reagents for Blood Cell AnalyzerGIF · Traditional	03/19/1980SE
K792482	Chemistry Analyzer ReagentsCIX · Traditional	01/11/1980SE
K792481	Culture Plates & Tubed MediaJTZ · Traditional	12/31/1979SE

Questions and answers

When was Stains, Counterstains & Gen. Purpose cleared by the FDA?

Stains, Counterstains & Gen. Purpose (K792483) received a 510(k) decision of Substantially Equivalent on December 18, 1979, 29 days after the submission was received.

What is the product code of K792483?

The FDA product code is ICL – Carbol Fuchsin, a Class I (low risk) device regulated under 21 CFR 864.1850.