FDA.reportPublic FDA data

ACRO BIOTECH Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30053604693005670738ACRO BIOTECH Inc.1N2026-01-014650 Arrow Hwy Suite D6 Montclair CA US 91763

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1546031180245657K964461ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TESTJHI1997-02-11
1546031167185541K960733MINISTICK PREGNANCY TESTLCX1996-05-01
1546031448276858K930014PROCLINIC ONE-STEP DIPSTICK PREGNANCY TESTJHI1993-03-25
1546032004765047K914254HOMECLINIC ONE STEP PREGNANCY TESTLCX1991-10-17
1546031381985246K914253PROCLINIC ONE STEP PREGNANCY TESTJHI1991-10-11
1546031473210359K910351MINICLINIC OVULATION PREDICTION TESTCEP1991-03-21
1546031946776725K252607AllTest Urinary Tract Infection TestJMT2025-10-30
1546031804060076K251053Shinetell PlusTM Digital Early Pregnancy TestLCX2025-07-15
1546031183720176K250727AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupNFT2025-04-04
1546031637572118K244043AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupNFT2025-02-27
1546032061005371K242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test PanelNFT2024-09-27
1546031154020788K241428AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test CupNFT2024-06-17
1546031813114518K234152ACESO Early Pregnancy TestLCX2024-04-05
1546031270226047K233417AllTest Fentanyl Urine Test CassetteNGL2023-10-26
1546031848708168K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxDKZ2023-12-13
1546031840895033K231698AllTest Fentanyl Rapid Test (Urine)DJG2023-07-31
1546031772163412K203272Alltest Pregnancy Rapid Combo Test CassetteJHI2022-01-31
1546031835993201K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)DKZ2019-03-27
1546031244518487K180771Acro HCG Pregnancy Rapid TestLCX2018-05-18
1546031130835122K172512ACRO HCG Pregnancy Rapid TestLCX2018-02-02
1546031803883615K111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTDIC2011-10-04
1546031212559144K061065FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25KHE2006-07-14
1546032011654629K060355ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000DJC2006-08-07
1546031642757471K060354ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000JXM2006-07-28
1546031638239129K060353ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000LCM2006-05-03
1546031090271359K053037ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100DJG2006-06-15
1546031989581177K053035ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000DIO2006-05-05
1546031648774245K053034ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000LDJ2006-06-06
1546031452153035K053033ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000DJC2006-06-06
1546031459443743K053032ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000DKZ2006-02-09
1546031956167837K051526URITEK-720+ URINE ANALYZERKQO2005-08-16
1546031000903977
1546031038260625
1546031754767239
1546031008454802
1546031011044638
1546031016122667
1546031028782147
1546031051474629
1546031055515617
1546031057995716
1546031058068067
1546031064712765
1546031065441804
1546031071114971
1546031089766770
1546031106216915
1546031106977666
1546031111707634
1546031119441476
1546031128169435
1546031139745755
1546031149897469
1546031152338055
1546031154368054
1546031160991166
1546031167386767
1546031172344023
1546031174458410
1546031183278495
1546031189182283
1546031191429865
1546031192571770
1546031204895105
1546031210752658
1546031213195967
1546031220718136
1546031242935035
1546031261835226
1546031262689158
1546031269895759
1546031270677593
1546031278727365
1546031296417597
1546031320752325
1546031331537370
1546031345505536
1546031352095757
1546031373358322
1546031397688759
1546031410553032
1546031413203600
1546031419682686
1546031422629572
1546031428090945
1546031428255894
1546031438438024
1546031464578691
1546031475228410
1546031481406183
1546031484164199
1546031487138672
1546031493859347
1546031496907565
1546031503763010
1546031505028742
1546031506991678
1546031510033239
1546031517184052
1546031538998911
1546031542817052
1546031565026527
1546031565324819
1546031574957451
1546031580704250
1546031581642577
1546031582046720
1546031585310476
1546031600171179
1546031611035752
1546031615669740
1546031623662686
1546031633025423
1546031635155858
1546031641441047
1546031668484163
1546031702970535
1546031714464549

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LCX62025-07-15
NFT42025-04-04
JHI42022-01-31
DKZ32023-12-13
DJG22023-07-31
DJC22006-08-07
JMT12025-10-30
NGL12023-10-26
DIC12011-10-04
JXM12006-07-28
KHE12006-07-14
LDJ12006-06-06
DIO12006-05-05
LCM12006-05-03
KQO12005-08-16
CEP11991-03-21