GJE · Tray, Blood Collection
Clinical Chemistry · 21 CFR 862.1675 · Class 2
Overview
| Product Code | GJE |
|---|---|
| Device Name | Tray, Blood Collection |
| Regulation | 21 CFR 862.1675 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.
Classification Rationale
Class II.
Cleared Devices (7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K962596 | CUSTOMED BLOOD EXTRACTION KIT | Customed, Inc. | Sep 27, 1996 | SESE |
| K925468 | JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT | J.J. Skinner, Inc. | Apr 11, 1994 | SEKD |
| K780303 | AUTO ISO-FILTER COLLECTION TUBE CAP | Bd Becton Dickinson Vacutainer Systems Preanalytic | Mar 30, 1978 | SESE |
| K771489 | RTERIAL BLOOD SAMPLING KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 22, 1977 | SESE |
| K771370 | ICROTAINEO BRAND TUBE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 3, 1977 | SESE |
| K761177 | SODIUM CITRATE | Bio/Data Corp. | Jan 10, 1977 | SESE |
| K760086 | TRAY, BLOOD SAMPLING (PULSATOR II) | Concord Laboratories, Inc. | Jul 16, 1976 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 3 clearances
- J.J. Skinner, Inc. — 1 clearance
- Customed, Inc. — 1 clearance
- Concord Laboratories, Inc. — 1 clearance
- Bio/Data Corp. — 1 clearance
