The following data is part of a premarket notification filed by Aesku.inc with the FDA for Aeskulisa Asca A.
Device ID | K051492 |
510k Number | K051492 |
Device Name: | AESKULISA ASCA A |
Classification | Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) |
Applicant | AESKU.INC 8880 NORTHWEST 18TH TERRACE Miami, FL 33172 |
Contact | Stanley Ammons |
Correspondent | Stanley Ammons AESKU.INC 8880 NORTHWEST 18TH TERRACE Miami, FL 33172 |
Product Code | NBT |
CFR Regulation Number | 866.5785 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-06-06 |
Decision Date | 2005-11-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847817018541 | K051492 | 000 |
00847817018534 | K051492 | 000 |
04250289503150 | K051492 | 000 |
04250289503143 | K051492 | 000 |
04250289502900 | K051492 | 000 |
04250289502894 | K051492 | 000 |
04250289501538 | K051492 | 000 |
04250289501521 | K051492 | 000 |