Para 12 Plus Retics
FDA 510(k) K000945 · Streck Laboratories, Inc.
510(k) numberK000945
Submission
- Device name
- Para 12 Plus Retics
- Applicant
- Streck Laboratories, Inc.
Omaha, NE, US - Received
- March 23, 2000
- Decision date
- April 18, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GLQ – Mixture, Control, White-Cell And Red-Cell Indices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
Other 510(k)s with product code GLQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K111211 | Cell-Dyn 22 Plus ControlGLQ · Traditional | Streck | 12/22/2011SE |
| K110718 | Cell-Chex with CPPD CrystalsGLQ · Traditional | Streck | 05/26/2011SE |
| K101335 | Cell-ChexGLQ · Traditional | Streck | 08/23/2010SE |
| K090137 | Stak-Chex Plus ReticsGLQ · Traditional | Streck | 03/18/2009SE |
| K994388 | Xe CheckGLQ · Traditional | Streck Laboratories, Inc. | 01/14/2000SE |
| K992887 | Stak-Chex Plus ReticsGLQ · Traditional | Streck Laboratories, Inc. | 11/22/1999SE |
| K823794 | Control TM 8GLQ · Traditional | General Diagnostics | 01/14/1983SE |
| K823587 | Uni-CellGLQ · Traditional | Medical Specialties Laboratories | 01/05/1983SE |
| K823498 | Para 12GLQ · Traditional | Streck Laboratories, Inc. | 12/28/1982SE |
More from Streck Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K042587 | Retic-Chex for Cell-DynJPK · Traditional | 10/19/2004SE |
| K040107 | Cyto-Chex BCTJKA · Traditional | 07/27/2004SE |
| K040025 | A1C-CELLULARJJX · Traditional | 03/02/2004SE |
| K023656 | Sickle-Chex Solubility KitGHM · Traditional | 12/30/2002SE |
| K021922 | Modification to Para 5XJPK · Special | 06/25/2002SE |
| K020469 | Cal-Chex CD PlusKRX · Traditional | 04/04/2002SE |
| K013316 | Sickle-ChexGHM · Traditional | 11/06/2001SE |
| K011410 | Para 5XJPK · Traditional | 06/26/2001SE |
| K001443 | Sugar Chex OneJJX · Traditional | 06/29/2000SE |
| K000115 | Retic Chex LinearityJPK · Traditional | 03/27/2000SE |
Questions and answers
When was Para 12 Plus Retics cleared by the FDA?
Para 12 Plus Retics (K000945) received a 510(k) decision of Substantially Equivalent on April 18, 2000, 26 days after the submission was received.
What is the product code of K000945?
The FDA product code is GLQ – Mixture, Control, White-Cell And Red-Cell Indices, a Class II (moderate risk) device regulated under 21 CFR 864.8625.