JZW
11 FDA 510(k) clearances · Product code
31 daysmedian time to decision
73 days90th percentile
11clearances measured
FDA profile
- Official device name
- Nephelometer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.4540
- Medical specialty
- Immunology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BN PROSPEC SYSTEM (K001647) | Dade Behring, Inc. | 2000-09-26 |
| BEHRING LASER NEPHELOMETER (K761234) | Behring Diagnostics, Inc. | 1990-06-07 |
| BEHRING NEPHELOMETER 100 (K892223) | Behring Diagnostics, Inc. | 1989-05-04 |
| TURBOX (K873401) | Unipath , Ltd. | 1987-09-23 |
| RRT SYSTEM LASER REFLECTOMETER ANALYZER (K873407) | Incstar Corp. | 1987-09-23 |
| BCM-302 COLLIMATING CONE & COMPENSATIN (K801949) | B C Medical , Ltd. | 1980-10-03 |
| DISC 120 TRANSPORTER (K801391) | Travenol Laboratories, S.A. | 1980-07-14 |
| LANCER L-INA BUFFER, POLYMER, WASH SOLU (K792014) | Sherwood Medical Industries | 1979-11-13 |
| IMMUNOCHEMISTRY SYS. MANUAL MODE (K781006) | Beckman Instruments, Inc. | 1978-08-31 |
| LASER STANDARD SERUM (K761235) | Behring Diagnostics, Inc. | 1976-12-30 |
| ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR. (K761236) | Behring Diagnostics, Inc. | 1976-12-30 |
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Every clearance here is in the API, with alerts when new ones post.