Panels › Hematology › Product code KHE · Class 2
Reagent, Occult Blood
Regulation 864.6550
0510(k)s in 12 months (97 all time)
2recalls in 12 months (19 all time)
16recalls that name a 510(k)
Top companies in KHE
| Company | 510(k)s | Recalls |
|---|---|---|
| Helena Laboratories | 12 | 2 |
| Immunostics Co., Inc. | 7 | 0 |
| Alere North Americal | 0 | 6 |
| Enterix, Inc. | 3 | 3 |
| Smithkline Diagnostics, Inc. | 4 | 0 |
| Aerscher Diagnostics | 3 | 0 |
| Alfa Scientific Designs, Inc. | 3 | 0 |
| Polymedco, Inc. | 1 | 2 |
| Propper Mfg. Co., Inc. | 3 | 0 |
| Ameritek USA, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 25, 1990 | K896474 | RESUBMITTED FECATWIN SENSITIVE - FECA-EIA Labsystems, Inc., FI | KHE |
| Apr 18, 1989 | K884206 | HEMAWIPE SYSTEM, THE CIVILIZED TEST Labeltape Meditect, Inc. | KHE |
| Oct 31, 1988 | K883432 | IMMUNOCCULT-LXI Intl. Immunoassay Laboratories, Inc. | KHE |
| Sep 30, 1988 | K882799 | HELENA COLOCARE Helena Laboratories | KHE |
| Sep 30, 1988 | K874180 | COLORECTAL CANCER RISK DETECTOR (TM) Pearce Clinical Laboratories, Inc. | KHE |
| Jul 8, 1988 | K881907 | HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD Enzo Biochem, Inc. | KHE |
| Jul 8, 1988 | K871143 | IMMUNOCCULT EIA TEST KIT Intl. Immunoassay Laboratories, Inc. | KHE |
| May 23, 1988 | K880499 | HEMOCCULT SENSITIVE TEST Smithkline Diagnostics, Inc. | KHE |
| May 13, 1988 | K874482 | REVISED IMMUDIA HEM-SP Schiff & Co. | KHE |
| Feb 11, 1988 | K873409 | WAKO(TM) PRETEST 6A Wako Chemicals USA, Inc. | KHE |
| Dec 9, 1986 | K862849 | HEMOCCULT WIPE TEST Smithkline Diagnostics, Inc. | KHE |
| Nov 6, 1986 | K861731 | NATURAL DETECTOR SYSTEM U.S. Health Resources Corp. | KHE |
| May 6, 1986 | K855237 | BIOTEL (TM)/ KIDNEY American Diagnostic Corp. | KHE |
| Apr 9, 1986 | K854358 | EZ DETECH-URINE BLOOD TEST STICKS Self Care Systems, Inc. | KHE |
| Apr 7, 1986 | K860028 | MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL Self Care Systems, Inc. | KHE |
| Mar 3, 1986 | K854619 | DETECTACULT Immunostics Co., Inc. | KHE |
| Nov 18, 1985 | K853141 | ACCESS DIGIWIPE SYSTEM Medtech Products, Inc. | KHE |
| Jun 17, 1985 | K850431 | EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL Nms Pharmaceuticals, Inc. | KHE |
| Jan 4, 1985 | K843601 | ACCESS HEMAWIPE Medtech Products, Inc. | KHE |
| Dec 12, 1984 | K843532 | UROPAPER EIKEN 8 Syn-Kit, Inc. | KHE |
| Dec 5, 1984 | K843352 | COLOSCREEN SELF-TEST Helena Laboratories | KHE |
| Sep 5, 1984 | K842137 | OCCULT BLOOD TEST Breit Laboratories, Inc. | KHE |
| Sep 5, 1984 | K840527 | COLOTRAK OCCULT BLOOD TEST Breit Laboratories, Inc. | KHE |
| Aug 16, 1984 | K840904 | ACCU-CULT FECAL OCCULT BLOOD TEST Applied Medical Devices, Inc. | KHE |
| Aug 10, 1984 | K840903 | HELENA COLOSCREEN SELF-TEST Helena Laboratories | KHE |
| Aug 2, 1984 | K833369 | EARLY DETECTOR Warner-Lambert Co. | KHE |
| Feb 27, 1984 | K832311 | HEMOCCULT-C Menley & James Laboratories | KHE |
| Jan 27, 1984 | K834297 | PROPPER SERACULT Propper Mfg. Co., Inc. | KHE |
| Jan 13, 1984 | K834456 | HELENA BIO STRIP OB Helena Laboratories | KHE |
| Nov 21, 1983 | K832864 | COLOSCREEN V.P.I. Helena Laboratories | KHE |
| Jul 7, 1983 | K830919 | OCCULT-ALERT Beta Med Pharmaceuticals, Inc. | KHE |
| Mar 7, 1983 | K830223 | FECAL OCCULT SLIDE TEST KIT Cambridge Chemical Products, Inc. | KHE |
| Oct 18, 1982 | K822731 | HEMOTECT Bio-Chem Laboratories | KHE |
| Oct 8, 1982 | K821884 | GASTROCCULT TM Smithkline Diagnostics, Inc. | KHE |
| Jul 2, 1982 | K812728 | FLEET DETECTATEST C.B. Fleet Co., Inc. | KHE |
| Mar 4, 1982 | K820072 | FE-CULT PLUS Gamma Biologicals, Inc. | KHE |
| Jan 28, 1982 | K813204 | SERACULT OCCULT BLOOF TEST Propper Mfg. Co., Inc. | KHE |
| Dec 10, 1981 | K811815 | UROPAPER EIKEG Syn-Kit, Inc. | KHE |
| Nov 2, 1981 | K811752 | FE-CULT PLUS Gamma Biologicals, Inc. | KHE |
| Oct 23, 1981 | K812428 | HELENA COLOSCREEN METHOD Helena Laboratories | KHE |
| May 8, 1981 | K810488 | HOME HEALTH CHEKUP KIT Healthkit | KHE |
| May 2, 1980 | K800433 | HELENA COLOCHECK Helena Laboratories | KHE |
| Jan 24, 1980 | K792655 | HELENA COLOSCREEN Helena Laboratories | KHE |
| Jun 30, 1978 | K780564 | FECATEST Otto C. Watzka | KHE |
| May 3, 1978 | K780214 | HEMO FEC Boehringer Mannheim Corp. | KHE |
| Feb 8, 1977 | K770153 | CAMCO R PAK-GUAIAC Cambridge Chemical Products, Inc. | KHE |
| Dec 21, 1976 | K761232 | QUICK CULT SLIDE TEST FECAL OCCULT BLOOD Laboratory Diagnostics Co., Inc. | KHE |
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