Para 12 Plus
FDA 510(k) K901875 · Streck Laboratories, Inc.
510(k) numberK901875
Submission
- Device name
- Para 12 Plus
- Applicant
- Streck Laboratories, Inc.
Omaha, NE, US - Received
- April 26, 1990
- Decision date
- May 30, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JCN – Control, Cell Counter, Normal And Abnormal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
Other 510(k)s with product code JCN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993825 | Para Tech Plus ReticsJCN · Traditional | Streck Laboratories, Inc. | 11/30/1999SE |
| K942209 | Liquichek HEMATOLOGY-16 Control, Low, Normal and HighJCN · Traditional | Bio-Rad | 06/16/1994SE |
| K934497 | Cbc-Stk(Tm) Hematology Control/MultipleJCN · Traditional | R&D Systems, Inc. | 12/06/1993SE |
| K911582 | Stak-ChexJCN · Traditional | Streck Laboratories, Inc. | 05/28/1991SE |
| K902391 | Cell-Dyn 3000 ControlJCN · Traditional | Unipath , Ltd. | 08/22/1990SE |
| K902389 | Tri-Count 16JCN · Traditional | Hematronix, Inc. | 08/22/1990SE |
| K896154 | Para Tech for Technicon H-1JCN · Traditional | Streck Laboratories, Inc. | 11/09/1989SE |
| K895373 | Hematology ControlJCN · Traditional | Medical Specialties Intl., Inc. | 10/06/1989SE |
| K891907 | Qbc(R) Centrifugal Hematology Contr/Multi ModifiedJCN · Traditional | R&D Systems, Inc. | 04/11/1989SE |
| K874386 | Cbc-Tech(Tm) Hematology Control/MultipleJCN · Traditional | R&D Systems, Inc. | 12/30/1987SE |
More from R&D Systems, 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 |
| K000945 | Para 12 Plus ReticsGLQ · Traditional | 04/18/2000SE |
Questions and answers
When was Para 12 Plus cleared by the FDA?
Para 12 Plus (K901875) received a 510(k) decision of Substantially Equivalent on May 30, 1990, 34 days after the submission was received.
What is the product code of K901875?
The FDA product code is JCN – Control, Cell Counter, Normal And Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.8625.