AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT
FDA 510(k) clearance K882907 · decided 1988-09-22
Clearance details
- K-number
- K882907
- Device name
- AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT
- Applicant
- Amersham Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-07-12
- Decision date
- 1988-09-22
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- JLW
- Device class
- 2
- Regulation number
- 862.1690
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Arlington Heights, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Amersham Corp.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.
Recalls involving this device
No recalls on record reference this clearance.