Company ยท US
Syntron Bioresearch, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 1999. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 6 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 3 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 3 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 3 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 3 |
| DIS | Enzyme Immunoassay, Barbiturate | 2 |
| DJG | Enzyme Immunoassay, Opiates | 2 |
| LCM | Enzyme Immunoassay, Phencyclidine | 2 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 29, 1999 | K993491 | QUICKPAC II ONE STEP OPIATES TEST Syntron Bioresearch, Inc. | DJG |
| Oct 29, 1999 | K993490 | QUICKSTRIP ONE STEP OPIATES TEST Syntron Bioresearch, Inc. | DJG |
| Sep 20, 1999 | K992990 | QUICKPAC II ONE STEP COCAINE TEST Syntron Bioresearch, Inc. | DIO |
| Sep 2, 1999 | K992748 | DRUGCHECK X MULTIDRUG SCREENING DEVICE Syntron Bioresearch, Inc. | DIO |
| Jul 22, 1999 | K992207 | QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM Syntron Bioresearch, Inc. | DIO |
| Jun 24, 1999 | K990325 | QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE Syntron Bioresearch, Inc. | DKZ |
| Nov 18, 1998 | K983113 | BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT Syntron Bioresearch, Inc. | CEP |
| May 26, 1998 | K981292 | QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST Syntron Bioresearch, Inc. | LCM |
| May 7, 1998 | K981019 | QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST Syntron Bioresearch, Inc. | LCM |
| Mar 3, 1998 | K980349 | QUICKPAC II ONE STEP BARBITURATE TEST Syntron Bioresearch, Inc. | DIS |
| Feb 12, 1998 | K974712 | QUIKSTRIP ONE STEP BARBITURATE TEST Syntron Bioresearch, Inc. | DIS |
| Feb 28, 1997 | K963654 | QUIKSTRIP ONESTEP MARIJUANA (THC) TEST Syntron Bioresearch, Inc. | LDJ |
| Dec 2, 1996 | K963341 | MIDSTREAM ONESTEP PREGNANCY HOME TEST Syntron Bioresearch, Inc. | LCX |
| Mar 19, 1996 | K960117 | PLATFORM ONESTEP PREGNANCY HOME TEST Syntron Bioresearch, Inc. | LCX |
| Aug 30, 1995 | K935554 | QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY Syntron Bioresearch, Inc. | GTZ |
| Aug 30, 1995 | K935475 | QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU Syntron Bioresearch, Inc. | GTZ |
| Jul 11, 1995 | K951538 | BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT Syntron Bioresearch, Inc. | CEP |
| Feb 8, 1995 | K945951 | QUIKPAC II, ONE STEP HCG COMBO KIT Syntron Bioresearch, Inc. | JHI |
| Apr 6, 1993 | K930488 | BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST Syntron Bioresearch, Inc. | LCX |
| Apr 6, 1993 | K924007 | QUIKPAC STREP A TEST Syntron Bioresearch, Inc. | GTZ |
| May 29, 1992 | K921099 | SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST Syntron Bioresearch, Inc. | LCX |
| Jul 24, 1991 | K912316 | QUIKPAC-II ONE STEP PREGNANCY HOME TEST Syntron Bioresearch, Inc. | LCX |
| Nov 4, 1987 | K874248 | SYNTRON BIORESEARCH U-TEST PREGNANCY TEST Syntron Bioresearch, Inc. | LCX |
| Jun 11, 1987 | K871602 | MICROCHECK LH OVULATION TEST Syntron Bioresearch, Inc. | CEP |
| May 20, 1987 | K870751 | SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST Syntron Bioresearch, Inc. | JHI |
| Feb 11, 1987 | K865076 | SYNTRON BIORESEARCH MICROCHECK HCG PREGNANCY TEST Syntron Bioresearch, Inc. | JHI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||