GAS-TRAK
Multi-analyte Controls, All Kinds (assayed)
UNITED DIAGNOSTICS, INC.
The following data is part of a premarket notification filed by United Diagnostics, Inc. with the FDA for Gas-trak.
Pre-market Notification Details
| Device ID | K862278 |
| 510k Number | K862278 |
| Device Name: | GAS-TRAK |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | UNITED DIAGNOSTICS, INC. 8 TECH CIRCLE Natick, MA 01760 |
| Contact | Norman Kleinman |
| Correspondent | Norman Kleinman UNITED DIAGNOSTICS, INC. 8 TECH CIRCLE Natick, MA 01760 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-16 |
| Decision Date | 1986-08-04 |
Trademark Results [GAS-TRAK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GAS-TRAK 77675451 not registered Dead/Abandoned |
Paragon Integrity Solutions, LLC 2009-02-22 |
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