FDA.reportPublic FDA data

CATACHEM, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
24341782434178CATACHEM, INC.1N2026-01-01353 Christian St Ste 2 Oxford CT US 06478

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00853618007011Catachem DiscretPak™ - Bile Acids (Colormetric) Kit C203-262-0330info@catacheminc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
376731718734285K945408340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZERCHJ1995-02-22
376731686550120K932871UIBC FOR DISCREET RANDOM ACCESS ANALYZERCFM1993-09-08
376731109121678K894715CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONSCGS1989-11-08
376731100587866K894476CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATIONCJY1989-10-12
376731692199798K894173BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICATCDQ1989-09-05
376731059061636K893885BACTON TM, BASIC TM, APO A-I REAGENTDEL1989-06-21
376732030915952K893884BACTON TM, BASIC TM, APO B REAGENTMSJ1989-06-21
376731493804908K892668TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONSCIG1989-07-20
376731188589913K891240DIRECT BILIRUBIN FOR CONTINUOUS FLOWCIG1989-05-10
376731468549901K874163ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTSCIX1987-11-23
376731955500494K872886CARBON DIOXIDEKMS1987-08-13
376731014155133K871543ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU.CJE1987-06-22
376731293876954K870086ALANINE AMINOTRANSFERASE (ALT)/(GPT)CKA1987-03-06
376731144979595K870077ASPARTATE AMINOTRANSFERASE (AST)/(GOT)CIT1987-03-06
376731420206496K860713LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM.CFJ1986-04-24
376731809247915K853826GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTSCFR1985-09-30
376731800435249K062503CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KITKWW2007-01-19
376731177834374
376731330313998
376731746856120
376731913832728
376731957060232
376731970821112
376732036465419
376732043262194

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CIG21989-07-20
KWW12007-01-19
CHJ11995-02-22
CFM11993-09-08
CGS11989-11-08
CJY11989-10-12
CDQ11989-09-05
MSJ11989-06-21
DEL11989-06-21
CIX11987-11-23
KMS11987-08-13
CJE11987-06-22
CKA11987-03-06
CIT11987-03-06
CFJ11986-04-24
CFR11985-09-30

PMN#

41 records. Showing 1-40. Next

GUDID#