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510(k) K912455

DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL by Baxter Healthcare Corp — Product Code JJY

K912455 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL". The FDA issued a decision of Substantially Equivalent on Aug 12, 1991. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Baxter Healthcare Corp has 507 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 12, 1991
Date Received
Jun 3, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type
510(k) Exempt

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Other clearances for product code JJY

  • K162530 — Multichem IA Plus (Mar 31, 2017)
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  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2… (Jan 10, 2017)
  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7… (Jan 28, 2016)
  • K150300 — Liquichek Cardiac Markers Plus Control LT (Dec 11, 2015)
  • K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit (Apr 30, 2015)
  • K143379 — Liquichek Maternal Serum II Control (Mar 13, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (Jan 16, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (Dec 8, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (Nov 20, 2014)

FDA data resources

Source: FDA 510(k) database entry for K912455. Report a data issue: hello@regdatalab.com.