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510(k) K892938

Device
Amnio-grow Tm
Applicant
INOVAR BIOLOGICALS, INC.
510(k) number
K892938
Product code
KIT
Decision
Substantially Equivalent (SESE)
Decision date
1989-05-22
Date received
1989-04-21
Regulation
864.2220
Classification name
Media And Components, Synthetic Cell And Tissue Culture
Medical specialty
Hematology
Review panel
Hematology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KEITH LATHAM
Address
7807 Cessna Ave. Gaithersburg MD US 20879 20879

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KIT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K890701ENDOTHELIAL GROWTH MEDIUM (EGM)Clonetics Corp.1989-02-24
K890700MELANOCYTE GROWTH MEDIUM (MGM)Clonetics Corp.1989-02-24
K890482ABC, ABC-1X, ABC(TM)Cell Ent., Inc.1989-02-10
K884654ALPHACALF SERUMHyclone Laboratories, Inc.1988-11-30
K884574DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785Sigma Chemical Co.1988-11-22
K884573HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891Sigma Chemical Co.1988-11-22
K884572RPMI-1640 HYBRI-MAX, PROD. NO. R5382Sigma Chemical Co.1988-11-22
K883065ALLOPREP SYSTEMOsteotech, Inc.1988-10-13
K884031FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENTRegency Biotech1988-10-06
K883951MEDIUM 199 W/EBSS (CATALOG NO. 200-2037)J R Scientific1988-09-30
K883682CHANG MEDIUM (ADDITIONAL INDICATIONS)Hana Biologics, Inc.1988-09-16
K883627MIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-2150J R Scientific1988-09-07
K883623EX-CELL 300TM, CATALOG NO. 200-3600J R Scientific1988-09-07
K883624EX-CELL 300TM, CATALOG NO. 200-3601J R Scientific1988-09-07
K883625EX-CELL 301, CATALOG NO. 200-3651J R Scientific1988-09-07