PARA 12 PLUS
FDA 510(k) clearance K901875 · decided 1990-05-30
Clearance details
- K-number
- K901875
- Device name
- PARA 12 PLUS
- Applicant
- Streck Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-04-26
- Decision date
- 1990-05-30
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- JCN
- Device class
- 2
- Regulation number
- 864.8625
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Omaha, NE, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PARA TECH PLUS RETICS (K993825) | Streck Laboratories, Inc. | 1999-11-30 |
| LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH (K942209) | Bio-Rad | 1994-06-16 |
| CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE (K934497) | R&D Systems, Inc. | 1993-12-06 |
| STAK-CHEX (K911582) | Streck Laboratories, Inc. | 1991-05-28 |
| CELL-DYN 3000 CONTROL (K902391) | Unipath , Ltd. | 1990-08-22 |
| TRI-COUNT 16 (K902389) | Hematronix, Inc. | 1990-08-22 |
| PARA TECH FOR TECHNICON H-1 (K896154) | Streck Laboratories, Inc. | 1989-11-09 |
| HEMATOLOGY CONTROL (K895373) | Medical Specialties Intl., Inc. | 1989-10-06 |
| QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED (K891907) | R&D Systems, Inc. | 1989-04-11 |
| CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE (K874386) | R&D Systems, Inc. | 1987-12-30 |
| HAEM-C PLUS BLOOD REFERENCE CONTROLS (K821956) | Baker Instructions Corp. | 1982-07-30 |
Recalls involving this device
No recalls on record reference this clearance.