MODEL 5500 CEAS
FDA 510(k) clearance K934977 · decided 1994-01-11
Clearance details
- K-number
- K934977
- Device name
- MODEL 5500 CEAS
- Applicant
- Esa, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-19
- Decision date
- 1994-01-11
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- CDF
- Device class
- 1
- Regulation number
- 862.1795
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bedford, MA, 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 |
|---|---|---|
| PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM (K953077) | Beckman Instruments, Inc. | 1996-01-05 |
| HVA EIA KIT YAMASA (K895288) | Yamasa Shoy Co., Ltd. | 1989-10-31 |
| VMA EIA KIT YAMASA (K895287) | Yamasa Shoy Co., Ltd. | 1989-10-30 |
| HVA & HOMOVANILLIC ACID BY HPLC METHOD (K873372) | Bio-Rad | 1987-12-22 |
| VANILMANDELIC ACID (VMA) REAGENT SET (K861962) | Sterling Diagnostics, Inc. | 1986-07-07 |
| VMA BY HPLC TEST (VANILMANDELIC ACID) (K861010) | Bio-Rad | 1986-05-01 |
| TRIGLYCERIDES LCK 124 (K853041) | German American Chamber of Commerce, Inc. | 1985-08-12 |
| VMA ASSAY KIT (K843379) | Diagnostic Chemicals, Ltd. (Usa) | 1984-09-28 |
| HELENA VMA-SMC COLUMN METHOD (K810992) | Helena Laboratories | 1981-04-29 |
| VMA BY COLUMN TEST (K791837) | Bio-Rad | 1979-10-30 |
| URINARY VMA - SCREEN TEST KIT (K772151) | Eppendorf-Brinkmann, Inc. | 1977-11-30 |
Recalls involving this device
No recalls on record reference this clearance.