JJ Skinner Carekits(Tm) Blood Collection Kit
FDA 510(k) K925468 · J.J. Skinner, Inc.
510(k) numberK925468
Submission
- Device name
- JJ Skinner Carekits(Tm) Blood Collection Kit
- Applicant
- J.J. Skinner, Inc.
Great Neck, NY, US - Received
- October 29, 1992
- Decision date
- April 11, 1994
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| K962596 | Customed Blood Extraction KitGJE · Traditional | Customed, Inc. | 09/27/1996SE |
| 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 |
More from Concord Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K961227 | JJ Skinner Carekits Wound Care Management/Dressing Change TrayFRG · Traditional | 06/10/1996SE |
| K961683 | JJ Skinner Carekits Minor Surgical Procedure TrayLRO · Traditional | 05/10/1996SE |
| K925469 | JJ Skinner Carekits(Tm) Dialysis On/Off KitFKG · Traditional | 05/03/1995SE |
| K925467 | JJ Skinner Carekits(Tm) Dry/Wet/Gel Skin Scrub KitLRO · Traditional | 05/11/1994SEKD |
| K903545 | Carekits(Tm), Iv/Cath/Cent Line Dress/Tpn/Cvp KitsFOZ · Traditional | 11/13/1990SEKD |
| K903544 | Carekits(Tm) Incision/Drainage/Suture Removal KitsLRP · Traditional | 08/31/1990SESD |
Questions and answers
When was JJ Skinner Carekits(Tm) Blood Collection Kit cleared by the FDA?
JJ Skinner Carekits(Tm) Blood Collection Kit (K925468) received a 510(k) decision of Unknown on April 11, 1994, 529 days after the submission was received.
What is the product code of K925468?
The FDA product code is GJE – Tray, Blood Collection, a Class II (moderate risk) device regulated under 21 CFR 862.1675.