FDA.reportPublic FDA data

Analytical Control Systems

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18257401825740Analytical Control Systems1N2026-01-019058 Technology Drive Fishers IN US 46038

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
00817869020281ACE Normal Control - SC-1313178410458marielle@analyticalcontrols.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
768801334974898K941115ACS CARDIO-TROL CONTROLJJY1994-07-20
768802008973395K940397ACS O DILVENT PROTEIN DILUTION MATRIXJJY1994-03-11
768801136146103K940272ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROLJJX1994-04-20
768801815589506K930477ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATORJIS1993-06-07
768801832831495K925340COAGULATION CONTROL CONTAINING HEMOGLOBINJPA1993-03-23
768801433067809K921118ACS APCT REAGENTGFO1992-07-28
768801763373248K904767ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBRJIX1990-12-26
768802032878634K902458ACS 0.02 M CALCIUM CHLORIDEJPA1990-08-01
768801166031044K902457ABNORMAL GLYCOHEMOGLOBIN CONTROLLCP1990-07-24
768801460959519K902455ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)LCP1990-07-24
768801973516939K894338ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL IIIGGC1989-07-25
768801492120606K893971ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL IIGGC1989-07-25
768801525273967K893783ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL IGIZ1989-06-23
768801854735860K892213ACS COLLOID OSMOTIC PRESSURE CALIBRATORJIW1989-06-21
768801586527678K863980U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TESTCJE1986-12-04
768801018538090K802569ABNORMAL HEMOGLOBIN CONTROLKHG1980-11-12
768801242030208K802568HEMOGLOBIN CONTROLKHG1980-11-12
768801803861598K800559SERTROL PRODUCT # ACS ST 101JJY1980-03-25
768801983587343K800558LIPID CONTROL PRODUCT # ACS LC 101JJY1980-03-25
768801975833616K800370CK/LD ISOENZYME CONTROL PROD. #ACS CT101JJY1980-03-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JJY51994-07-20
KHG41980-11-12
JJX21994-04-20
JIS21993-06-07
JPA21993-03-23
LCP21990-07-24
GGC21989-07-25
GFO11992-07-28
JIX11990-12-26
GIZ11989-06-23
JIW11989-06-21
CJE11986-12-04

PMN#

42 records. Showing 1-40. Next

GUDID#