REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO)
FDA 510(k) clearance K901463 · decided 1990-06-12
Clearance details
- K-number
- K901463
- Device name
- REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO)
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1990-03-28
- Decision date
- 1990-06-12
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- JQJ
- Device class
- 1
- Regulation number
- 862.1630
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Beaumont, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Helena Laboratories
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.
Recalls involving this device
No recalls on record reference this clearance.