ACRO BIOTECH Inc.
Montclair, CA, US
ACRO BIOTECH Inc. appears in FDA device records in Montclair, CA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for ACRO BIOTECH Inc. between 2006 and 2018. The busiest year on record is 2006, with 8. The most recent is 2018, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 8 |
| 2018 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K180771 | Acro HCG Pregnancy Rapid Test | LCX | Substantially Equivalent | |
| K172512 | ACRO HCG Pregnancy Rapid Test | LCX | Substantially Equivalent | |
| K060355 | ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000 | DJC | Substantially Equivalent | |
| K060354 | ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000 | JXM | Substantially Equivalent | |
| K053037 | ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100 | DJG | Substantially Equivalent | |
| K053034 | ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000 | LDJ | Substantially Equivalent | |
| K053033 | ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000 | DJC | Substantially Equivalent | |
| K053035 | ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 | DIO | Substantially Equivalent | |
| K060353 | ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 | LCM | Substantially Equivalent | |
| K053032 | ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000 | DKZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005360469 | 3005670738 | ACRO BIOTECH Inc. | 4650 Arrow Hwy Suite D6, Montclair, CA 91763 US | 2026 | and 128 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GKAAbnormal Hemoglobin Quantitation
- DCFAlbumin, Antigen, Antiserum, Control
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- GNQAntigen, Cf (Including Cf Control), Epstein-Barr Virus
- KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
- JWLAntigen, Treponema Pallidum For Fta-Abs Test
- GSOAntigens (Febrile), Agglutination, Brucella Spp.
- GRLAntigens, All Groups, Salmonella Spp.
- GTYAntigens, All Groups, Streptococcus Spp.
- GMZAntigens, All Types, Escherichia Coli
- GRYAntigens, All, Leptospira Spp.
- GODAntigens, Cf (Including Cf Control), Adenovirus 1-33
- GSBAntigens, Cf, All, Mycoplasma Spp.
- GRTAntiserum, Fluorescent, Mycobacterium Tuberculosis
- GSQAntiserum, Vibrio Cholerae, All Varieties
- KQOAutomated Urinalysis System
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- JIOBlood, Occult, Colorimetric, In Urine
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- LDPColorimetry, Acetaminophen
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- JXNEnzyme Immunoassay, Propoxyphene
- DBFFerritin, Antigen, Antiserum, Control
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- JHXFluorometric Method, Cpk Or Isoenzymes
- LAFGas Chromatography, Methamphetamine
- JNMImmunochemical, Transferrin
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- DEGLactoferrin, Antigen, Antiserum, Control
- DNILiquid Chromatography, Amphetamine
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- CFQRadioimmunoassay, Immunoglobulins (G, A, M)
- DLBRadioimmunoassay, Lsd (125-I)
- CEPRadioimmunoassay, Luteinizing Hormone
- KXSRadioimmunoassay, Methaqualone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- KHEReagent, Occult Blood
- DKEReagents, Test, Tetrahydrocannabinol
- JRERefractometer For Clinical Use
- DGBSeminal Fluid, Antigen, Antiserum, Control
- KSJSystem, Identification, Hepatitis B Antigen
- DHXSystem, Test, Carcinoembryonic Antigen
- DHRSystem, Test, Rheumatoid Factor
- DJCThin Layer Chromatography, Methamphetamine
- DNKThin Layer Chromatography, Morphine
- DPNThin Layer Chromatography, Propoxyphene
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain