510(k) K801391
- Device
- Disc 120 Transporter
- Applicant
- TRAVENOL LABORATORIES, S.A.
- 510(k) number
- K801391
- Product code
- JZW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-07-14
- Date received
- 1980-06-13
- Regulation
- 866.4540
- Classification name
- Nephelometer
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3008517993
- 3017379203
- 9610529
- 3014325803
- 3014100717
- 9610126
- 3006198300
- 3003795116
- 3003601075
- 9610806
- 2432235
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JZW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K001647 | BN PROSPEC SYSTEM | Dade Behring, Inc. | 2000-09-26 |
| K761234 | BEHRING LASER NEPHELOMETER | Behring Diagnostics, Inc. | 1990-06-07 |
| K892223 | BEHRING NEPHELOMETER 100 | Behring Diagnostics, Inc. | 1989-05-04 |
| K873401 | TURBOX | Unipath , Ltd. | 1987-09-23 |
| K873407 | RRT SYSTEM LASER REFLECTOMETER ANALYZER | Incstar Corp. | 1987-09-23 |
| K801949 | BCM-302 COLLIMATING CONE & COMPENSATIN | B C Medical , Ltd. | 1980-10-03 |
| K792014 | LANCER L-INA BUFFER, POLYMER, WASH SOLU | Sherwood Medical Industries | 1979-11-13 |
| K781006 | IMMUNOCHEMISTRY SYS. MANUAL MODE | Beckman Instruments, Inc. | 1978-08-31 |
| K761235 | LASER STANDARD SERUM | Behring Diagnostics, Inc. | 1976-12-30 |
| K761236 | ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR. | Behring Diagnostics, Inc. | 1976-12-30 |