UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD
FDA 510(k) clearance K980525 · decided 1998-04-15
Clearance details
- K-number
- K980525
- Device name
- UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD
- Applicant
- Marukin Shoyu Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1998-02-11
- Decision date
- 1998-04-15
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- KWX
- Device class
- 2
- Regulation number
- 862.1187
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Marukin Shoyu Co.
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.
| Record | Firm | Date |
|---|---|---|
| UBAS (K993941) | Marukin Diagnostics | 2000-03-02 |
Recalls involving this device
No recalls on record reference this clearance.