Customed Blood Extraction Kit
FDA 510(k) K962596 · Customed, Inc.
510(k) numberK962596
Submission
- Device name
- Customed Blood Extraction Kit
- Applicant
- Customed, Inc.
Great Neck,, NY, US - Received
- July 2, 1996
- Decision date
- September 27, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GJE – Tray, Blood Collection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Specialty
- Clinical Chemistry
Other 510(k)s with product code GJE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K925468 | JJ Skinner Carekits(Tm) Blood Collection KitGJE · Traditional | J.J. Skinner, Inc. | 04/11/1994SEKD |
| K780303 | Auto Iso-Filter Collection Tube CapGJE · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/30/1978SE |
| K771489 | Rterial Blood Sampling KitGJE · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/22/1977SE |
| K771370 | Icrotaineo Brand TubeGJE · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/03/1977SE |
| K761177 | Sodium CitrateGJE · Traditional | Bio/Data Corp. | 01/10/1977SE |
| K760086 | Tray, Blood Sampling (Pulsator II)GJE · Traditional | Concord Laboratories, Inc. | 07/16/1976SE |
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| K964011 | Suction Catheter Tray Product No. 900277LRO · Traditional | 11/25/1996SESK |
| K962652 | Urinary Drainage Bag, (Reorder No. 0749 - Product No. 900-749)KNX · Traditional | 10/04/1996SE |
| K961442 | Universal Drainage TrayFCM · Traditional | 05/09/1996SE |
| K953678 | Sterimed Sterization Wrapper (Non-Sterile)FRG · Traditional | 10/02/1995SE |
| K950295 | Wound Closure/Laceration TrayLRO · Traditional | 04/18/1995SE |
| K942177 | Foley Catheterization TrayFCM · Traditional | 09/08/1994SE |
| K925018 | IV Prep Kit W/O Dressing (Non-Sterile)LRS · Traditional | 08/27/1993SEKD |
Questions and answers
When was Customed Blood Extraction Kit cleared by the FDA?
Customed Blood Extraction Kit (K962596) received a 510(k) decision of Substantially Equivalent on September 27, 1996, 87 days after the submission was received.
What is the product code of K962596?
The FDA product code is GJE – Tray, Blood Collection, a Class II (moderate risk) device regulated under 21 CFR 862.1675.