Panels › Clinical Chemistry › Product code DHA · Class 2
System, Test, Human Chorionic Gonadotropin
Regulation 862.1155
0510(k)s in 12 months (72 all time)
0recalls in 12 months (14 all time)
11recalls that name a 510(k)
Top companies in DHA
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 2, 1994 | K941090 | UNISTEP HCG PREGNANCY TEST STRIP Biotech Atlantic, Inc. | DHA |
| Jun 29, 1993 | K932409 | SAS(TM) SERUM/URINE HCG Sa Scientific, Inc. | DHA |
| Oct 19, 1992 | K922073 | STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY Baxter Diagnostics, Inc. | DHA |
| Aug 16, 1991 | K913236 | STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY Baxter Healthcare Corp | DHA |
| Jun 20, 1991 | K911796 | IMMULITE(TM) HCG Cirrus Diagnostics, Inc. | DHA |
| Aug 21, 1989 | K893873 | SINGLE AND DUAL BAND DIPSTICK HCG TEST Ampcor, Inc. | DHA |
| Aug 15, 1989 | K893953 | ABSOLUTE(TM)-HCG URINE PREGNANCY TEST Totem Diagnostics, Inc., CA | DHA |
| Aug 3, 1989 | K893577 | STATUS HCG FLUOROMETRIC ENZYME Baxter Healthcare Corp | DHA |
| Jun 19, 1989 | K892654 | BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST Princeton Biomedix | DHA |
| Jun 16, 1989 | K891096 | VIS-DISK HCG (EIA) JPL-041M Leeco Diagnostics, Inc. | DHA |
| Jun 16, 1989 | K891095 | VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M Leeco Diagnostics, Inc. | DHA |
| Dec 9, 1988 | K884430 | SERUM HCG MICROASSAY Diamedix Corp. | DHA |
| Dec 5, 1988 | K883148 | IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40 Diagnostic Chemicals, Ltd. (Usa), CA | DHA |
| Dec 2, 1988 | K884207 | RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO Abbott Laboratories | DHA |
| Nov 10, 1988 | K882192 | HYGEIA URINE PREGNANCY TEST Hygeia Sciences | DHA |
| Oct 31, 1988 | K882896 | ONE-STEP HCG Wampole Laboratories | DHA |
| Oct 12, 1988 | K882895 | MODIFIED BETA QUIK STAT EIA KIT Pacific Biotech, Inc. | DHA |
| Sep 30, 1988 | K883235 | RAPIDTEST-HCG (TM) Synbiotics Corp. | DHA |
| Apr 5, 1988 | K880678 | MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY Ventrex Laboratories, Inc. | DHA |
| Feb 2, 1988 | K873986 | BETA-HCG ASSAY Schiff & Co. | DHA |
| Oct 28, 1987 | K873872 | HCG ENZYME IMMUNOASSAY TEST KIT CATALOG #MB-1013 Medix Biotech, Inc. | DHA |
| Aug 19, 1986 | K862108 | ENZYMUN-TEST HCG Boehringer Mannheim Corp. | DHA |
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