ANTIBIOTIC NEPHELOMETER
FDA 510(k) clearance K781644 · decided 1978-10-03
Clearance details
- K-number
- K781644
- Device name
- ANTIBIOTIC NEPHELOMETER
- Applicant
- Biovation, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-09-25
- Decision date
- 1978-10-03
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- JQX
- Device class
- 1
- Regulation number
- 862.2700
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, 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 |
|---|---|---|
| IMMAGE IMMUNOCHEMISTRY SYSTEM (K962294) | Beckman Instruments, Inc. | 1996-08-21 |
| ARRAY(R) 360 (K922273) | Beckman Instruments, Inc. | 1992-08-19 |
| QMS(TM) - THEOPHYLLINE (K885263) | Seradyn, Inc. | 1989-03-28 |
| TDX ANALYZER W/NEPHELOMETRY CAROUSEL (K851253) | Abbott Laboratories | 1985-04-30 |
| A-JUST TURBIDITY METER (K851234) | Abbott Laboratories | 1985-04-29 |
| ALBUMIN NEPHELOMETRIC ASSAY (K801362) | J.T. Baker Chemical Co. | 1980-07-21 |
| J.T. BAKER NEPHELOMETER (K801089) | J.T. Baker Chemical Co. | 1980-05-28 |
| BIOVATION NEPHELOMETER (K792045) | Biovation, Inc. | 1979-10-30 |
| NEPHELOMETER, MIC-2000 LASER (K790103) | Dynatech Corp. | 1979-03-12 |
| RAD-291 (K781554) | Organon, Inc. | 1978-10-11 |
| NEPHELOMETER (K780251) | Kallestad Laboratories, Inc. | 1978-04-06 |
| LASER IMMUNONEPHELOMETRIC ANALYZER (K772361) | G.D. Searle and Co. | 1978-01-30 |
Recalls involving this device
No recalls on record reference this clearance.