Tray, Blood Collection
The Tray, Blood Collection (product code GJE) is an ancillary device used to organize and hold blood collection supplies such as tubes, needles, and other accessories during venipuncture or phlebotomy procedures in clinical chemistry settings. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 862.1675 in the Clinical Chemistry specialty (CH), it is eligible for third-party review.
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Basic Information
- Product Code
- GJE
- Device Class
- FDA class 2
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K962596 | CUSTOMED BLOOD EXTRACTION KIT | Sep 27, 1996 | Substantially Equivalent | Customed, Inc. |
| K925468 | JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT | Apr 11, 1994 | Unknown | J.J. Skinner, Inc. |
| K780303 | AUTO ISO-FILTER COLLECTION TUBE CAP | Mar 30, 1978 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K771489 | RTERIAL BLOOD SAMPLING KIT | Aug 22, 1977 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K771370 | ICROTAINEO BRAND TUBE | Aug 03, 1977 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K761177 | SODIUM CITRATE | Jan 10, 1977 | Substantially Equivalent | Bio/Data Corp. |
| K760086 | TRAY, BLOOD SAMPLING (PULSATOR II) | Jul 16, 1976 | Substantially Equivalent | Concord Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.