TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL)
FDA 510(k) clearance K884747 · decided 1989-01-30
Clearance details
- K-number
- K884747
- Device name
- TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL)
- Applicant
- Technicon Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-11-14
- Decision date
- 1989-01-30
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- CKB
- Device class
- 2
- Regulation number
- 862.1020
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tarrytown, NY, 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 |
|---|---|---|
| DRI-STAT ACID PHOSPHATASE REAGENT (K053612) | Beckman Coulter, Inc. | 2006-04-26 |
| ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 (K023840) | Bayer Diagnostics Corp. | 2003-01-07 |
| ACP (K991010) | Abbott Diagnostics Mfg., Inc. | 1999-05-19 |
| OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER (K981743) | Olympus America, Inc. | 1998-06-09 |
| COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) (K974695) | Roche Diagnostic Systems, Inc. | 1998-05-21 |
| OLYMPUS ACID PHOSPHATASE REAGENT (K963640) | Olympus America, Inc. | 1997-02-18 |
| IL TEST ACID PHOSPHATASE (K943366) | Instrumentation Laboratory CO | 1996-01-29 |
| ACID PHOSPHOTASE REAGENT TEST AND KIT (K902543) | Crestat Diagnostics, Inc. | 1990-09-07 |
| ACID PHOSPHATASE REAGENT SET (K902495) | Tech Intl. Co. | 1990-07-16 |
| ACID PHOSPHATASE REAGENT (K892393) | Medical Analysis Systems, Inc. | 1989-07-20 |
| ACP KINETIC TEST (ACID PHOSPHATASE TEST) (K881204) | Sclavo, Inc. | 1988-04-28 |
| ACID PHOSPHATASE REAGENT (K880798) | Trace America, Inc. | 1988-04-18 |
Recalls involving this device
No recalls on record reference this clearance.