510(k) K771370
- Device
- ICROTAINEO BRAND TUBE
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K771370
- Product code
- GJE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-08-03
- Date received
- 1977-07-25
- Regulation
- 862.1675
- Classification name
- Tray, Blood Collection
- Medical specialty
- Clinical Chemistry
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 1875 Eye St. NW Suite 625 Washington DC US 20006 20006
FDA Registration Numbers#
- 1928237
- 1423395
- 2648727
- 1036781
- 3005012805
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GJE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K962596 | CUSTOMED BLOOD EXTRACTION KIT | Customed, Inc. | 1996-09-27 |
| K925468 | JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT | J.J. Skinner, Inc. | 1994-04-11 |
| K780303 | AUTO ISO-FILTER COLLECTION TUBE CAP | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-03-30 |
| K771489 | RTERIAL BLOOD SAMPLING KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-08-22 |
| K761177 | SODIUM CITRATE | Bio/Data Corp. | 1977-01-10 |
| K760086 | TRAY, BLOOD SAMPLING (PULSATOR II) | Concord Laboratories, Inc. | 1976-07-16 |
Legacy Summary#
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FDA Review#
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