HELENA BIOSTRIP A
FDA 510(k) clearance K830978 · decided 1983-05-13
Clearance details
- K-number
- K830978
- Device name
- HELENA BIOSTRIP A
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1983-03-29
- Decision date
- 1983-05-13
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- JMA
- Device class
- 1
- Regulation number
- 862.1095
- 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 |
|---|---|---|
| QUANTIMETRIX C-CLEAR(TM) (K931523) | Quantimetrix Corp. | 1993-06-25 |
| URITEST 9, INLAB REAGENT STRIPS URINALY (K822709) | Laprol Scientific, Inc. | 1983-01-28 |
Recalls involving this device
No recalls on record reference this clearance.