510(k) K812969
- Device
- S/p Capillary Tubes, Heparinized (2a)
- Applicant
- AMERICAN DADE
- 510(k) number
- K812969
- Product code
- GIO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-11-06
- Date received
- 1981-10-22
- Regulation
- 864.6150
- Classification name
- Tube, Collection, Capillary Blood
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers
- 8043905
- 2249801
- 3005572604
- 1119779
- 9610633
- 3030530726
- 3009169953
- 3027645317
- 3030733800
- 1618982
- 1933913
- 2432235
- 8010932
- 2518153
- 3006975595
- 3015341499
- 3003310007
- 3015525148
- 1000555938
- 3013530901
- 2244900
- 3021244152
- 3043088937
- 3004959793
- 3005739529
- 3019387954
- 3011765035
- 3002637618
- 3016748351
- 3002807968
- 3006446479
- 3007490412
- 3016710934
- 2243072
- 3010834934
- 3003393069
- 9617475
- 3043138885
- 8020040
- 3012315023
- 1220649
- 3027605742
- 1616487
- 3000682787
- 3002805583
- 3004008703
- 1064584
- 3006808300
- 9610126
- 3012494290
- 3006101929
- 3010194621
- 3016096098
- 3011671735
- 3002808145
- 3015908492
- 3010879605
- 3043226252
- 3007185216
- 3013846070
- 3017450368
- 3004102403
- 3009435759
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GIO
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972969 | QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM | Innovative Medical Technologies, Inc. | 1997-09-22 |
| K941291 | MONOJECT SAMPLETTE SEPARATOR TUBE | Sherwood Medical Co. | 1994-10-27 |
| K894851 | TRU-TRAX | Humagen, Inc. | 1989-09-29 |
| K885324 | HEMA(PRO)TEC(TION) | Medical Products Search, Inc. | 1989-02-17 |
| K885138 | CAPILLARY TUBE, BLOOD COLLECTION | Coeur Laboratories, Inc. | 1989-02-07 |
| K884623 | SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE | Safe-Tec Clinical Products, Inc. | 1988-12-01 |
| K881262 | CARAWAY TUBES, HEPARIN AND PLAIN | Helps Products, Inc. | 1988-05-06 |
| K881187 | NATELSON TUBES, HEPARIN AND PLAIN | Helps Products, Inc. | 1988-05-06 |
| K875061 | MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR | Sherwood Medical Co. | 1988-01-12 |
| K873647 | VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE | Ventrex Laboratories, Inc. | 1987-10-20 |
| K850806 | CORNING BLOOD COLLECTION CAPILLARY TUBES | Corning Medical & Scientific | 1985-03-25 |
| K843608 | CAPILLARY BLOOD COLLECTION TUBE | Medical Technomics, Ltd. | 1984-11-30 |
| K843892 | MICRO HEMATOCRIT CAPILLARY TUBES | Abco Dealers, Inc. | 1984-11-13 |
| K843362 | RINGCAPS | Medical Technomics, Ltd. | 1984-09-21 |
| K843361 | MINICAPS | Medical Technomics, Ltd. | 1984-09-21 |