510(k) K800189

Device: BOVINE ALBUMIN 22% & 30% SOLUTIONS
Applicant: GOTHAM BIOLOGICS, INC.
510(k) number: K800189
Product code: KSG
Decision: Substantially Equivalent (SESE)
Decision date: 1980-02-13
Date received: 1980-01-29
Regulation: 864.9600
Classification name: Media, Potentiating For In Vitro Diagnostic Use
Medical specialty: Hematology
Review panel: Clinical Chemistry
Device class: 2
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

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

FDA Registration Numbers#

9610824
3004910133
3012963943
2250051
1319681
1177732
1034569
3016014873
3002642396
3017237798
3000308930
3006261638
3011683976

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KSG #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K812565	ELUTION SOLUTION	Biological Corp. of America	1981-10-23
K812222	EM-X	Biological Corp. of America	1981-09-23
K800943	PENTEX BOVINE ALBUMIN 30% SOLUTION	Miles Laboratories, Inc.	1980-05-08
K791791	ORTHO ANTIBODY ENHANCEMENT SOLUTION	Ortho Diagnostics, Inc.	1979-10-11
K791113	LOW IONIC STRENGTH SOLUTION (LISS)	Hyland Therapeutic Div., Travenol Laboratories	1979-06-28
K790973	LO-ION	Gamma Biologicals, Inc.	1979-06-15
K790776	DADE LOW IONIC STRENGTH SOLUITION (LISS)	Dade, Baxter Travenol Diagnostics, Inc.	1979-05-23
K790498	LISS REAGENT	Fisher Scientific Co., LLC	1979-04-03
K781397	EM-V	Biological Corp. of America	1978-09-14
K781435	ORTHO LOW IONIC SOLUTION	Ortho Diagnostics, Inc.	1978-09-14
K780413	LOW IIONIC STRENGTH SOLUTION	Pfizer, Inc.	1978-04-24
K780556	SPECT RIM (LISS)	Bd Becton Dickinson Vacutainer Systems Preanalytic	1978-04-24

Legacy Summary#

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