BEHRING NEPHELOMETER 100
FDA 510(k) clearance K892223 · decided 1989-05-04
Clearance details
- K-number
- K892223
- Device name
- BEHRING NEPHELOMETER 100
- Applicant
- Behring Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-04-03
- Decision date
- 1989-05-04
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- JZW
- Device class
- 1
- Regulation number
- 866.4540
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Somerville, NJ, 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 |
|---|---|---|
| BN PROSPEC SYSTEM (K001647) | Dade Behring, Inc. | 2000-09-26 |
| BEHRING LASER NEPHELOMETER (K761234) | Behring Diagnostics, Inc. | 1990-06-07 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OPUS(R) CEA TEST SYSTEM (P920021/S001) | Behring Diagnostics, Inc. | 1996-02-23 |