The following data is part of a premarket notification filed by Schiapparelli Biosystems, Inc. with the FDA for Ace(tm) Clin Chem Syst W/opt Ion Select Electr(ise).
| Device ID | K933862 |
| 510k Number | K933862 |
| Device Name: | ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE) |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | SCHIAPPARELLI BIOSYSTEMS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Contact | Mark A Spain |
| Correspondent | Mark A Spain SCHIAPPARELLI BIOSYSTEMS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-09 |
| Decision Date | 1993-10-12 |