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 |