Haem-C Plus Blood Reference Controls
FDA 510(k) K821956 · Baker Instructions Corp.
510(k) numberK821956
Submission
- Device name
- Haem-C Plus Blood Reference Controls
- Applicant
- Baker Instructions Corp.
Mchenry, IL, US - Received
- June 30, 1982
- Decision date
- July 30, 1982
- 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 |
| K901875 | Para 12 PlusJCN · Traditional | Streck Laboratories, Inc. | 05/30/1990SE |
| 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 |
More from R&D Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K882612 | System 9000 Diff Model Automated Cell CounterGKZ · Traditional | 09/07/1988SE |
| K873596 | Baker TDM Theophylline AssayKLS · Traditional | 10/20/1987SE |
| K870603 | System 9000 Automated Cell CounterGKL · Traditional | 03/31/1987SE |
| K854173 | Ucd Urine Specimen CollectorKNX · Traditional | 11/04/1985SE |
| K850386 | System 8000 Cell CounterGKL · Traditional | 05/02/1985SE |
| K833116 | Spirit Chemistry SystemJJE · Traditional | 11/07/1983SE |
| K832716 | Encore Chemistry AnalyzerJJG · Traditional | 10/04/1983SE |
| K830641 | Encore Chemistry AnalyzerJJG · Traditional | 04/05/1983SE |
| K811694 | Centrifichem Alt/Agpt Optimized ReagentCKA · Traditional | 07/01/1981SE |
Questions and answers
When was Haem-C Plus Blood Reference Controls cleared by the FDA?
Haem-C Plus Blood Reference Controls (K821956) received a 510(k) decision of Substantially Equivalent on July 30, 1982, 30 days after the submission was received.
What is the product code of K821956?
The FDA product code is JCN – Control, Cell Counter, Normal And Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.8625.