The following data is part of a premarket notification filed by Supelco, Inc. with the FDA for Solid Phase Extraction Tubes.
Device ID | K881361 |
510k Number | K881361 |
Device Name: | SOLID PHASE EXTRACTION TUBES |
Classification | Ion-exchange Chromatography |
Applicant | SUPELCO, INC. SUPELCO PARK Bellefonte, PA 16823 -0048 |
Contact | Lloyd A Witting |
Correspondent | Lloyd A Witting SUPELCO, INC. SUPELCO PARK Bellefonte, PA 16823 -0048 |
Product Code | DJY |
CFR Regulation Number | 862.2230 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-16 |
Decision Date | 1988-08-08 |