Syntron Bioresearch, Inc.
Carlsbad, CA, US
SYNTRON BIORESEARCH, INC. appears in FDA device records in Carlsbad, CA. FDA records list 26 510(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 26 510(k) clearances for Syntron Bioresearch, Inc. between 1987 and 1999. The busiest year on record is 1999, with 6. The most recent is 1999, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 4 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 2 |
| 1995 | 4 |
| 1996 | 2 |
| 1997 | 1 |
| 1998 | 5 |
| 1999 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K993491 | QUICKPAC II ONE STEP OPIATES TEST | DJG | Substantially Equivalent | |
| K993490 | QUICKSTRIP ONE STEP OPIATES TEST | DJG | Substantially Equivalent | |
| K992990 | QUICKPAC II ONE STEP COCAINE TEST | DIO | Substantially Equivalent | |
| K992748 | DRUGCHECK X MULTIDRUG SCREENING DEVICE | DIO | Substantially Equivalent | |
| K992207 | QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM | DIO | Substantially Equivalent | |
| K990325 | QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE | DKZ | Substantially Equivalent | |
| K983113 | BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT | CEP | Substantially Equivalent | |
| K981292 | QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST | LCM | Substantially Equivalent | |
| K981019 | QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST | LCM | Substantially Equivalent | |
| K980349 | QUICKPAC II ONE STEP BARBITURATE TEST | DIS | Substantially Equivalent | |
| K974712 | QUIKSTRIP ONE STEP BARBITURATE TEST | DIS | Substantially Equivalent | |
| K963654 | QUIKSTRIP ONESTEP MARIJUANA (THC) TEST | LDJ | Substantially Equivalent | |
| K963341 | MIDSTREAM ONESTEP PREGNANCY HOME TEST | LCX | Substantially Equivalent | |
| K960117 | PLATFORM ONESTEP PREGNANCY HOME TEST | LCX | Substantially Equivalent | |
| K935554 | QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY | GTZ | Substantially Equivalent | |
| K935475 | QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU | GTZ | Substantially Equivalent | |
| K951538 | BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT | CEP | Substantially Equivalent | |
| K945951 | QUIKPAC II, ONE STEP HCG COMBO KIT | JHI | Substantially Equivalent | |
| K930488 | BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST | LCX | Substantially Equivalent | |
| K924007 | QUIKPAC STREP A TEST | GTZ | Substantially Equivalent | |
| K921099 | SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST | LCX | Substantially Equivalent | |
| K912316 | QUIKPAC-II ONE STEP PREGNANCY HOME TEST | LCX | Substantially Equivalent | |
| K874248 | SYNTRON BIORESEARCH U-TEST PREGNANCY TEST | LCX | Substantially Equivalent | |
| K871602 | MICROCHECK LH OVULATION TEST | CEP | Substantially Equivalent | |
| K870751 | SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST | JHI | Substantially Equivalent | |
| K865076 | SYNTRON BIORESEARCH MICROCHECK HCG PREGNANCY TEST | JHI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2025760 | 2025760 | SYNTRON BIORESEARCH, INC. | 2774 LOKER AVE. WEST, CARLSBAD, CA 92010 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GTZAntisera, All Groups, Streptococcus Spp.
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- CEPRadioimmunoassay, Luteinizing Hormone
- NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter
- NGETest, Luteinizing Hormone (Lh), Over The Counter
- 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