The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Carbon Dioxide Liquid Stable Reagent.
Device ID | K070251 |
510k Number | K070251 |
Device Name: | CARBON DIOXIDE LIQUID STABLE REAGENT |
Classification | Enzymatic, Carbon-dioxide |
Applicant | POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE Canton, MI 48188 |
Contact | William F Walters, Jr |
Correspondent | William F Walters, Jr POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE Canton, MI 48188 |
Product Code | KHS |
CFR Regulation Number | 862.1160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-01-26 |
Decision Date | 2007-04-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00811727014979 | K070251 | 000 |
00811727016102 | K070251 | 000 |
00811727010667 | K070251 | 000 |
00811727010674 | K070251 | 000 |
00811727010681 | K070251 | 000 |
00811727012616 | K070251 | 000 |
00811727012623 | K070251 | 000 |
00811727012630 | K070251 | 000 |
00811727013453 | K070251 | 000 |
00811727015792 | K070251 | 000 |