Germaine Laboratories, Inc.
San Antonio, TX, US
GERMAINE LABORATORIES, INC. appears in FDA device records in San Antonio, TX. FDA records list 8 510(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 8 510(k) clearances for Germaine Laboratories, Inc. between 1997 and 2005. The busiest year on record is 1998, with 4. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1998 | 4 |
| 1999 | 1 |
| 2002 | 1 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K051727 | AIMSTICK URINE REAGENT STRIPS | CEN | Substantially Equivalent | |
| K013857 | AIMSTEP PREGNANCY | DHA | Substantially Equivalent | |
| K991369 | ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY | LCX | Substantially Equivalent | |
| K981165 | AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST | JHI | Substantially Equivalent | |
| K980531 | AIMSTEP PREGNANCY | JHI | Substantially Equivalent | |
| K974512 | AIMSTICK PBD COMBO PREGNANCY | DHA | Substantially Equivalent | |
| K974368 | AIMSTICK PBD PREGNANCY | DHA | Substantially Equivalent | |
| K973825 | MIDSTREAM HOME REGNANCY TEST | DHA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1649661 | 3001451797 | GERMAINE LABORATORIES, INC. | 11030 Wye Drive, SAN ANTONIO, TX 78217 US | 2026 | and 69 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- GSOAntigens (Febrile), Agglutination, Brucella Spp.
- GRLAntigens, All Groups, Salmonella Spp.
- GTYAntigens, All Groups, Streptococcus Spp.
- GSZAntigens, Febrile (Weil-Felix), All Groups
- GNCAntigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
- GMQAntigens, Nontreponemal, All
- GSLAntigens, Slide And Tube, Francisella Tularensis
- GRMAntisera, All Groups, Salmonella Spp.
- GSYAntisera, Fluorescent, All Globulins, Proteus Spp.
- GSMAntisera, Fluorescent, Brucella Spp.
- GSKAntiserum, Francisella Tularensis
- GSNAntiserum, Positive And Negative Febrile Antigen Control Serum
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- KQOAutomated Urinalysis System
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- JIOBlood, Occult, Colorimetric, In Urine
- JGYColorimetric Method, Triglycerides
- GGMControl, Hemoglobin
- DJZDevices, Breath Trapping, Alcohol
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- CIGDiazo Colorimetry, Bilirubin
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- DIFDrug Mixture Control Materials
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JFYEnzymatic Method, Creatinine
- 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
- LAFGas Chromatography, Methamphetamine
- CGAGlucose Oxidase, Glucose
- LYRHelicobacter Pylori
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- LBRLdl & Vldl Precipitation, Hdl
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- CEPRadioimmunoassay, Luteinizing Hormone
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
- KHEReagent, Occult Blood
- DSFRecorder, Paper Chart
- JRERefractometer For Clinical Use
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- GKRSystem, Hemoglobin, Automated
- DCNSystem, Test, C-Reactive Protein
- DHASystem, Test, Human Chorionic Gonadotropin
- KTNSystem, Test, Infectious Mononucleosis
- DHRSystem, Test, Rheumatoid Factor
- LJXTest, Urine Leukocyte
- JJWUrinalysis Controls (Assayed And Unassayed)
- 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