510(k) K953077
- Device
- PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM
- Applicant
- BECKMAN INSTRUMENTS, INC.
- 510(k) number
- K953077
- Product code
- CDF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-01-05
- Date received
- 1995-06-30
- Regulation
- 862.1795
- Classification name
- Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SHERI L HALL
- Address
- 200 S. Kraemer Blvd. W-337 Brea CA US 92821 92821
FDA Registration Numbers#
- 2915274
- 3003951180
Source Documents#
Other 510(k) Records For Product Code CDF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K934977 | MODEL 5500 CEAS | Esa, Inc. | 1994-01-11 |
| K895288 | HVA EIA KIT YAMASA | Yamasa Shoy Co., Ltd. | 1989-10-31 |
| K895287 | VMA EIA KIT YAMASA | Yamasa Shoy Co., Ltd. | 1989-10-30 |
| K873372 | HVA & HOMOVANILLIC ACID BY HPLC METHOD | Bio-Rad | 1987-12-22 |
| K861962 | VANILMANDELIC ACID (VMA) REAGENT SET | Sterling Diagnostics, Inc. | 1986-07-07 |
| K861010 | VMA BY HPLC TEST (VANILMANDELIC ACID) | Bio-Rad | 1986-05-01 |
| K853041 | TRIGLYCERIDES LCK 124 | German American Chamber of Commerce, Inc. | 1985-08-12 |
| K843379 | VMA ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-09-28 |
| K810992 | HELENA VMA-SMC COLUMN METHOD | Helena Laboratories | 1981-04-29 |
| K791837 | VMA BY COLUMN TEST | Bio-Rad | 1979-10-30 |
| K772151 | URINARY VMA - SCREEN TEST KIT | Eppendorf-Brinkmann, Inc. | 1977-11-30 |
Legacy Summary#
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FDA Review#
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