510(k) K962596
- Device
- CUSTOMED BLOOD EXTRACTION KIT
- Applicant
- CUSTOMED, INC.
- 510(k) number
- K962596
- Product code
- GJE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-09-27
- Date received
- 1996-07-02
- Regulation
- 862.1675
- Classification name
- Tray, Blood Collection
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROLANN KOTULA
- Address
- 55 Northern Blvd., Suite 410 Great Neck, NY US 11021 11021
FDA Registration Numbers#
- 1928237
- 1423395
- 2648727
- 1036781
- 3005012805
Source Documents#
Other 510(k) Records For Product Code GJE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K771370 | ICROTAINEO BRAND TUBE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-08-03 |
| K761177 | SODIUM CITRATE | Bio/Data Corp. | 1977-01-10 |
| K760086 | TRAY, BLOOD SAMPLING (PULSATOR II) | Concord Laboratories, Inc. | 1976-07-16 |
Legacy Summary#
summary
FDA Review#
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