WEIL ONCOMETER (IL 186)
FDA 510(k) clearance K760975 · decided 1977-01-12
Clearance details
- K-number
- K760975
- Device name
- WEIL ONCOMETER (IL 186)
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 1976-11-03
- Decision date
- 1977-01-12
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- JJK
- Device class
- 1
- Regulation number
- 862.2720
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Instrumentation Laboratory CO
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT (K863099) | Abbott Laboratories | 1986-09-16 |
| SPECIAL CONTROL SERUM FOR HDL-CHOLES (K823196) | Boehringer Mannheim Corp. | 1982-11-29 |
| HEPA-SHURE -L (K802120) | Nuclear Medical Laboratories, Inc. | 1980-10-20 |
Recalls involving this device
No recalls on record reference this clearance.