Panels › Hematology › Product code KHG · Class 2
Whole Blood Hemoglobin Determination
Regulation 864.7500
0510(k)s in 12 months (39 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in KHG
| Company | 510(k)s | Recalls |
|---|---|---|
| Miles Laboratories, Inc. | 4 | 0 |
| Gds Technology | 3 | 0 |
| Abbott Laboratories | 2 | 0 |
| Boehringer Mannheim Corp. | 2 | 0 |
| Marilyn L. Amick | 2 | 0 |
| Sanguina, Inc. | 2 | 0 |
| Analytical Products, Inc. | 1 | 0 |
| Anco Medical Reagents & Assoc. | 1 | 0 |
| Awareness Technology, Inc. | 1 | 0 |
| Biorent Diagnostic, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 29, 2023 | K221508 | AnemoCheck Home Sanguina, Inc. | KHG |
| Sep 13, 2017 | K163215 | AnemoCheck Sanguina, LLC | KHG |
| Dec 15, 2004 | K042379 | ANEMIAPRO SELF-SCREENER Biosafe Laboratories, Inc. | KHG |
| Feb 11, 2002 | K020138 | STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 Gds Technology | KHG |
| Aug 21, 2000 | K001462 | CARESIDE HEMOGLOBIN Careside, Inc. | KHG |
| Jan 14, 2000 | K994073 | HEMOSITE TEST SYSTEM Gds Technology, LLC | KHG |
| Aug 31, 1998 | K973649 | HEMOSITE TEST SYSTEM Gds Technology, LLC | KHG |
| Sep 29, 1995 | K953221 | ABBOTT VISION HEMOGLOBIN (MODIFICATION) Abbott Laboratories | KHG |
| Dec 6, 1993 | K934064 | REFLOTRON HEMOGLOBIN TEST TABS Boehringer Mannheim Corp. | KHG |
| Oct 10, 1989 | K895101 | BIOTRACK HEMOGLOBIN TEST CARTRIDGE Biotrack, Inc. | KHG |
| Feb 24, 1989 | K885227 | CLINISTAT HEMOGLOBIN REAGENT TEST Heraeus Kulzer, Inc. | KHG |
| Apr 21, 1988 | K880038 | FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 Sigma Diagnostics, Inc. | KHG |
| Jul 23, 1987 | K872653 | EASY-TEST HEMOGLOBIN (HGB) ITEM #16685 Em Diagnostic Systems, Inc. | KHG |
| Mar 16, 1987 | K870363 | HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD Trace Scientific , Ltd., AU | KHG |
| Sep 4, 1986 | K863104 | TOTAL HEMOGLOBIN J. D. Assoc. | KHG |
| Aug 21, 1986 | K862641 | U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK) U. S. Diagnostics, Inc. | KHG |
| Aug 18, 1986 | K862202 | VISION(TM) HEMOGLOBIN Abbott Laboratories | KHG |
| Jun 4, 1986 | K854687 | ERMA HB-METER MODEL 303N Future Impex Corp. | KHG |
| Mar 3, 1986 | K860475 | HEMOGLOBIN REAGENT SET Sterling Diagnostics, Inc. | KHG |
| Nov 5, 1985 | K854139 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB Eastman Kodak Company | KHG |
| Jul 16, 1985 | K851467 | HEMOGLOBIN ANALYZER Awareness Technology, Inc. | KHG |
| Jul 12, 1985 | K851432 | HEMOGLOBIN Pointe Scientific, Inc., | KHG |
| Sep 26, 1983 | K832750 | EASYTOUCH HEMOGLOBIN REAGENT Worthington Diagnostic Systems | KHG |
| Jul 28, 1983 | K831813 | CO-OXIMETER CONTROL United Diagnostics, Inc. | KHG |
| Apr 8, 1983 | K830180 | REFEREE BRAND CO-OXIMETER REAGENTS Analytical Products, Inc. | KHG |
| Apr 5, 1983 | K830590 | CORNING 2500 CO-OXIMETER Corning Medical & Scientific | KHG |
| Nov 22, 1982 | K823060 | HEMOGLOBIN REAGENT Biorent Diagnostic, Inc. | KHG |
| Jul 30, 1982 | K822045 | SERALYZER HEMOGLOBIN TEST MODULE Miles Laboratories, Inc. | KHG |
| Jul 30, 1982 | K822044 | SERALYZER HEMOGLOBIN REAGENT STRIPS Miles Laboratories, Inc. | KHG |
| Jun 25, 1982 | K821658 | HEMOGLOBIN REAGENT Anco Medical Reagents & Assoc. | KHG |
| Mar 26, 1982 | K820596 | CYANMETHEMOGLOBIN TEST Boehringer Mannheim Corp. | KHG |
| Jan 26, 1981 | K803248 | AMES SERA-PAK HEMOGLOBIN REAGENT Miles Laboratories, Inc. | KHG |
| Dec 31, 1980 | K802268 | CRC(CYANMETHEMOGLOBIN REAGENT CONCENT R&D Systems, Inc. | KHG |
| Nov 12, 1980 | K802569 | ABNORMAL HEMOGLOBIN CONTROL Marilyn L. Amick | KHG |
| Nov 12, 1980 | K802568 | HEMOGLOBIN CONTROL Marilyn L. Amick | KHG |
| Jul 14, 1980 | K801268 | HEMOGLOBIN CONTROL LEVELS Bioscientific | KHG |
| Apr 4, 1980 | K800059 | COMPUR M-1000 MINI-PHOTOMETER Miles Laboratories, Inc. | KHG |
| Dec 31, 1979 | K792503 | SANDARE CYANMETHEMOGLOBIN REAGENT Sandare Chemical Co., Inc. | KHG |
| Jul 26, 1976 | K760208 | OXIMETER, CO-, IL MODEL 282 Instrumentation Laboratory CO | KHG |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.