ICROTAINEO BRAND TUBE
FDA 510(k) clearance K771370 · decided 1977-08-03
Clearance details
- K-number
- K771370
- Device name
- ICROTAINEO BRAND TUBE
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1977-07-25
- Decision date
- 1977-08-03
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- GJE
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| CUSTOMED BLOOD EXTRACTION KIT (K962596) | Customed, Inc. | 1996-09-27 |
| JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT (K925468) | J.J. Skinner, Inc. | 1994-04-11 |
| AUTO ISO-FILTER COLLECTION TUBE CAP (K780303) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-03-30 |
| RTERIAL BLOOD SAMPLING KIT (K771489) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-08-22 |
| SODIUM CITRATE (K761177) | Bio/Data Corp. | 1977-01-10 |
| TRAY, BLOOD SAMPLING (PULSATOR II) (K760086) | Concord Laboratories, Inc. | 1976-07-16 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Vacutainer Microtainer Serum tubes (with or without gel). recall (Z-1603-05) | Becton Dickinson & Company | 2004-10-28 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |