URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)— 510(k) K970277
Substantially EquivalentAstoria-Pacific, Inc.
FDA 510(k) clearance K970277 for URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K), Substantially Equivalent on 1997-12-11. Applicant: Astoria-Pacific, Inc.. Device class: 2.
Clearance details
- Applicant
- Astoria-Pacific, Inc.
- Product code
- Code KQP
- Device class
- Class 2
- Regulation
- 21 CFR 862.1315
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Clackamas, OR, US
Recent devices under product code KQP
view allMore clearances from Astoria-Pacific, Inc.
view all- K121101 — SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT
- K090940 — SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
- K080294 — ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT
- K010844 — ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K
- K990957 — ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K
Recalls naming K970277
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970277.
Data sourced from openFDA. This site is unofficial and independent of the FDA.