HEPA-SHURE -L
FDA 510(k) clearance K802120 · decided 1980-10-20
Clearance details
- K-number
- K802120
- Device name
- HEPA-SHURE -L
- Applicant
- Nuclear Medical Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-09-04
- Decision date
- 1980-10-20
- Days to decision
- 46 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
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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 |
|---|---|---|
| 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 |
| WEIL ONCOMETER (IL 186) (K760975) | Instrumentation Laboratory CO | 1977-01-12 |
Recalls involving this device
No recalls on record reference this clearance.