A1C-CELLULAR
Single (specified) Analyte Controls (assayed And Unassayed)
STRECK LABORATORIES, INC.
The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for A1c-cellular.
Pre-market Notification Details
| Device ID | K040025 |
| 510k Number | K040025 |
| Device Name: | A1C-CELLULAR |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | STRECK LABORATORIES, INC. 7002 SOUTH 109TH ST. La Vista, NE 68128 |
| Contact | Kerrie Oetter |
| Correspondent | Kerrie Oetter STRECK LABORATORIES, INC. 7002 SOUTH 109TH ST. La Vista, NE 68128 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-07 |
| Decision Date | 2004-03-02 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844509001003 | K040025 | 000 |
| 00844509000945 | K040025 | 000 |
| 00844509000938 | K040025 | 000 |
Trademark Results [A1C-CELLULAR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 A1C-CELLULAR 78544055 3134491 Live/Registered |
STRECK, INC. 2005-01-07 |
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