Panels › Clinical Chemistry › Product code JHI · Class 2
Visual, Pregnancy Hcg, Prescription Use
Regulation 862.1155
1510(k)s in 12 months (376 all time)
4recalls in 12 months (47 all time)
34recalls that name a 510(k)
Top companies in JHI
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 18, 1997 | K965253 | SAS PREGNANCY STRIP Sascie | JHI |
| Feb 18, 1997 | K965250 | SAS SERUM/URINE HCG Sascie | JHI |
| Feb 11, 1997 | K964536 | ONE-STEP DIPSTICK PREGNANCY TEST Teco Diagnostics | JHI |
| Feb 11, 1997 | K964462 | ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST Teco Diagnostics | JHI |
| Feb 11, 1997 | K964461 | ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST Teco Diagnostics | JHI |
| Feb 4, 1997 | K965227 | OSOM CLASSIC HCG-URINE TEST (115) Wyntek Diagnostics, Inc. | JHI |
| Jan 21, 1997 | K964995 | SAS ONE-STEP PREGNANCY Sa Scientific, Inc. | JHI |
| Jan 21, 1997 | K964574 | AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST Athena Medical Corp. | JHI |
| Dec 4, 1996 | K963231 | EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST Excel Scientific, Inc. | JHI |
| Nov 25, 1996 | K964156 | CONTRAST STRIP HCG Genzyme Diagnostics | JHI |
| Nov 25, 1996 | K964155 | CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST Genzyme Diagnostics | JHI |
| Nov 18, 1996 | K963133 | PS-UNIT CASSETTE/SERUM HCG International Newtech Development, Inc., CA | JHI |
| Nov 18, 1996 | K963132 | MINI STRIP/SERUM HCG International Newtech Development, Inc., CA | JHI |
| Oct 18, 1996 | K963408 | VISUALINE D HCG Sun Biomedical Laboratories, Inc. | JHI |
| Aug 23, 1996 | K962906 | SCRIPPS LABORATORIES HCG ONE-STEP Scripps Laboratories, Inc. | JHI |
| Jul 10, 1996 | K954065 | BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT Biochem Immunosystems (U.S.), Inc. | JHI |
| Jun 28, 1996 | K961911 | DSL ACTIVE I-HCG ELISA Diagnostic Systems Laboratories, Inc. | JHI |
| May 7, 1996 | K960357 | DSL ACTIVE I-HCG IRMA Diagnostic Systems Laboratories, Inc. | JHI |
| Apr 25, 1996 | K960992 | BIONIKE A/Q PREGNANCY TEST Bionike Laboratories, Inc. | JHI |
| Mar 19, 1996 | K955353 | ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT Tcpi, Inc. | JHI |
| Feb 29, 1996 | K955266 | ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT Boehringer Mannheim Italia Spa | JHI |
| Dec 21, 1995 | K953486 | MIT ONE STEP PREGNANCY TEST 3c Diagnostics, Inc., TW | JHI |
| Dec 13, 1995 | K954993 | QUIX RAPID PREGNANCY STRIP TEST Guardian Scientific, Corp. | JHI |
| Dec 11, 1995 | K954901 | BIONIKE A/Q PREGNANCY TEST Bionike Laboratories, Inc. | JHI |
| Nov 20, 1995 | K954732 | ACCESS TOTAL BHCG ASSAY (MODIFICATION) Bio-Rad Laboratories, Inc. | JHI |
| Oct 16, 1995 | K954273 | CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG Quidel Corp. | JHI |
| Oct 5, 1995 | K954029 | TESTPACK PLUS HCG URINE Abbott Laboratories | JHI |
| Oct 3, 1995 | K951705 | MINISTRIP HCG International Newtech Development, Inc., CA | JHI |
| Aug 29, 1995 | K953383 | WYNTEK OSOM HCG-URINE TEST Wyntek Diagnostics, Inc. | JHI |
| Jun 20, 1995 | K952319 | CONTRAST & RAPID HCG URINE/SERUM TST Medix Biotech, Inc. | JHI |
| Apr 20, 1995 | K951136 | BIONIKE A/Q PREGNANCY TEST Charlton Assoc. | JHI |
| Feb 10, 1995 | K943859 | QUICK CHECKER HCG PREGNANCY TEST Mizuho USA, Inc. | JHI |
| Feb 8, 1995 | K945951 | QUIKPAC II, ONE STEP HCG COMBO KIT Syntron Bioresearch, Inc. | JHI |
| Jan 27, 1995 | K945969 | RAPIDVUE(TM) HCG Quidel Corp. | JHI |
| Dec 7, 1994 | K943239 | VISUALINE II HCG Sun Biomedical Laboratories, Inc. | JHI |
| Oct 25, 1994 | K944426 | BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE Princeton BioMeditech Corp. | JHI |
| Sep 20, 1994 | K942464 | UC QIK 1-STEP HCG TEST Eucardio Laboratory, Inc. | JHI |
| Jun 21, 1994 | K935673 | AXSYM TOTAL B-HCG Abbott Laboratories | JHI |
| Apr 15, 1994 | K936031 | ONE STEP PREGNANCY TEST Teco Diagnostics | JHI |
| Apr 8, 1994 | K936287 | KODAK SURECELL HCG URINE TEST, MODIFICATION Eastman Kodak Company | JHI |
| Apr 8, 1994 | K936138 | KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION Eastman Kodak Company | JHI |
| Jan 27, 1994 | K935502 | EVENT TEST STRIP HCG Boehringer Mannheim Italia Spa | JHI |
| Nov 5, 1993 | K931698 | KINGS BAY PRELUDE ONE STEP HCG COMBO KIT King'S Bay Intl., Inc. | JHI |
| Sep 28, 1993 | K932758 | MEDIX BIOTECH BESTEST HCG-URINE TEST KIT Medix Biotech, Inc. | JHI |
| Jul 8, 1993 | K932279 | OPUS(R) TOTAL B-HCG TEST SYSTEM Pb Diagnostic Systems, Inc. | JHI |
| Jun 29, 1993 | K932042 | QUICKVUE ONE-STEP HCG COMBO Quidel Corp. | JHI |
| Jun 15, 1993 | K925303 | PRO-STEP PT HCG Disease Detection International, Inc. | JHI |
| Jun 9, 1993 | K931302 | SAS PREGNANCY STRIP Sa Scientific, Inc. | JHI |
| Jun 7, 1993 | K926500 | UC QIK PREGNANCY TEST Eucardio Laboratory, Inc. | JHI |
| May 11, 1993 | K924673 | CLEARVIEW HCG Unipath , Ltd., GB | JHI |
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