TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL— 510(k) K972868
Substantially EquivalentBionostics, Inc.
FDA 510(k) clearance K972868 for TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL, Substantially Equivalent on 1997-08-28. Applicant: Bionostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Bionostics, Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Acton, MA, US
Recent devices under product code JJY
view all- K162530 — Multichem IA Plus
- K163629 — Audit MicroControls Linearity FD Tumor Markers II
- K163015 — Liquichek Tumor Marker Control-Level 1 +3 more
- K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
- K150300 — Liquichek Cardiac Markers Plus Control LT
More clearances from Bionostics, Inc.
view allRecalls naming K972868
K-number listed on FDA's recall record- Z-1314-2024 — Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL
- Z-1315-2024 — Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K972868.
Data sourced from openFDA. This site is unofficial and independent of the FDA.