510(k) K841059

Device: SGPT REAGENT SET
Applicant: MEDICAL SPECIALTIES, INC.
510(k) number: K841059
Product code: CKD
Decision: Substantially Equivalent (SESE)
Decision date: 1984-05-01
Date received: 1984-03-12
Regulation: 862.1030
Classification name: Hydrazone Colorimetry, Alt/sgpt
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 1
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: 803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

3010891909
8040374
1832216
3017936791
3043648115
3010583458

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CKD #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K991834	CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772	Cholestech Corp.	1999-09-09
K941192	ORTHO ALT MICROWELL TEST SYSTEM	Ortho Diagnostic Systems, Inc.	1995-05-16
K896237	COBAS READY ALT REAGENT	Roche Diagnostic Systems, Inc.	1990-02-16
K884784	VIRGO(R) MICROWELL ALT ASSAY	Electro-Nucleonics, Inc.	1988-12-29
K883387	ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)	Tech-Co, Inc.	1988-10-13
K864082	REFLOTRON(R) ALT (GPT)	Boehringer Mannheim Corp.	1986-12-04
K860485	SGPT (ALT) REAGENT SET (COLORIMETRIC)	Sterling Diagnostics, Inc.	1986-04-03
K844283	SGPT REAGENT SET	Livonia Diagnostics, Inc.	1984-11-27
K821207	SGPT REAGENT SET	Omega Medical Electronics	1982-07-14
K820491	SGPT REAGENT SET	Anco Medical Reagents & Assoc.	1982-03-11

Legacy Summary#

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