V-MARC 88A COMPUTER
FDA 510(k) clearance K871853 · decided 1987-07-16
Clearance details
- K-number
- K871853
- Device name
- V-MARC 88A COMPUTER
- Applicant
- V.Marc, A Div. of Pictorial, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-05-12
- Decision date
- 1987-07-16
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- JQP
- Device class
- 1
- Regulation number
- 862.2100
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, 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 |
|---|---|---|
| BIONIME DIABETES MANAGEMENT SYSTEM VI.0 (K113007) | Bionime Corporation | 2012-02-27 |
| FASTTAKE ADAPTER, MODEL # P/N 020-072-01 (K983468) | Selfcare, Inc. | 1998-12-17 |
| THE ROBOLITE (K964460) | Shai Syg Motion and Innovations, Ltd. | 1997-01-24 |
| PRENVAL I (K953652) | Base Ten Systems, Inc. | 1995-09-15 |
| MR7000 WITH TIME MANAGER SOFTWARE (TMS) (K934111) | Dynatech Laboratories, Inc. | 1994-11-02 |
| EXPRESSO CARTRIDGE (K923316) | Bio-Rad Laboratories, Inc. | 1993-02-23 |
| MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER (K893838) | Ciba Corning Diagnostics Corp. | 1989-08-31 |
| CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM (K892060) | Syva Co. | 1989-08-10 |
| COBAS MFC (K885292) | Roche Diagnostic Systems, Inc. | 1989-03-22 |
| RIA-QUICK (K881194) | Quantitative Technologies, Inc. | 1988-06-01 |
| KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM (K871339) | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-05-15 |
| 710 PLUS (K864557) | Ciba Corning Diagnostics Corp. | 1987-02-25 |
Recalls involving this device
No recalls on record reference this clearance.