Panels › Hematology › Product code GIO · Class 1
Tube, Collection, Capillary Blood
Regulation 864.6150
0510(k)s in 12 months (22 all time)
13recalls in 12 months (25 all time)
0recalls that name a 510(k)
Top companies in GIO
| Company | 510(k)s | Recalls |
|---|---|---|
| ASP Global, LLC. dba Anatomy Supply Partners, LLC. | 0 | 13 |
| American Dade | 5 | 0 |
| Drummond Scientific Co | 0 | 4 |
| Radiometer America Inc | 0 | 4 |
| Medical Technomics, Ltd. | 3 | 0 |
| Radiometer Medical ApS | 0 | 3 |
| Sherwood Medical Co. | 3 | 0 |
| Helps Products, Inc. | 2 | 0 |
| Abco Dealers, Inc. | 1 | 0 |
| Coeur Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 22, 1997 | K972969 | QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM Innovative Medical Technologies, Inc. | GIO |
| Oct 27, 1994 | K941291 | MONOJECT SAMPLETTE SEPARATOR TUBE Sherwood Medical Co. | GIO |
| Sep 29, 1989 | K894851 | TRU-TRAX Humagen, Inc. | GIO |
| Feb 17, 1989 | K885324 | HEMA(PRO)TEC(TION) Medical Products Search, Inc. | GIO |
| Feb 7, 1989 | K885138 | CAPILLARY TUBE, BLOOD COLLECTION Coeur Laboratories, Inc. | GIO |
| Dec 1, 1988 | K884623 | SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE Safe-Tec Clinical Products, Inc. | GIO |
| May 6, 1988 | K881262 | CARAWAY TUBES, HEPARIN AND PLAIN Helps Products, Inc. | GIO |
| May 6, 1988 | K881187 | NATELSON TUBES, HEPARIN AND PLAIN Helps Products, Inc. | GIO |
| Jan 12, 1988 | K875061 | MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR Sherwood Medical Co. | GIO |
| Oct 20, 1987 | K873647 | VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE Ventrex Laboratories, Inc. | GIO |
| Mar 25, 1985 | K850806 | CORNING BLOOD COLLECTION CAPILLARY TUBES Corning Medical & Scientific | GIO |
| Nov 30, 1984 | K843608 | CAPILLARY BLOOD COLLECTION TUBE Medical Technomics, Ltd. | GIO |
| Nov 13, 1984 | K843892 | MICRO HEMATOCRIT CAPILLARY TUBES Abco Dealers, Inc. | GIO |
| Sep 21, 1984 | K843362 | RINGCAPS Medical Technomics, Ltd. | GIO |
| Sep 21, 1984 | K843361 | MINICAPS Medical Technomics, Ltd. | GIO |
| Aug 31, 1983 | K832578 | MONOJET SAMPLETTE ADAPTERS Sherwood Medical Co. | GIO |
| Nov 6, 1981 | K812970 | S/P CAPILLARY TUBES, HEPARINIZED (3A) American Dade | GIO |
| Nov 6, 1981 | K812969 | S/P CAPILLARY TUBES, HEPARINIZED (2A) American Dade | GIO |
| Nov 6, 1981 | K812923 | S/P SURE-CAP N American Dade | GIO |
| Nov 6, 1981 | K812922 | S/P SURE-CAP C American Dade | GIO |
| Nov 6, 1981 | K812921 | S/P SURE-CAP American Dade | GIO |
| Jul 11, 1977 | K770981 | LANCER CAPILLARY BLOOD SERUM SEPARATOR Sherwood Medical Industries | GIO |
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