The following data is part of a premarket notification filed by Biotech, Inc. with the FDA for Cryolock.
Device ID | K122982 |
510k Number | K122982 |
Device Name: | CRYOLOCK |
Classification | Labware, Assisted Reproduction |
Applicant | BIOTECH, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
Contact | Robyn Scopis |
Correspondent | Robyn Scopis BIOTECH, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
Product Code | MQK |
CFR Regulation Number | 884.6160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-26 |
Decision Date | 2014-01-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B056CLRCTY5 | K122982 | 000 |
B056SCLC5 | K122982 | 000 |
B056SCLG5 | K122982 | 000 |
B056SCLO5 | K122982 | 000 |
B056SCLY5 | K122982 | 000 |
B056CLRCT2 | K122982 | 000 |
B056CLRCTB2 | K122982 | 000 |
B056CLRCTC5 | K122982 | 000 |
B056CLRCTG2 | K122982 | 000 |
B056CLRCTO5 | K122982 | 000 |
B056SCLB5 | K122982 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CRYOLOCK 86874718 5071706 Live/Registered |
Biotech Incorporated 2016-01-13 |
CRYOLOCK 86863525 5071666 Live/Registered |
Biotech Incorporated 2015-12-31 |
CRYOLOCK 86583691 not registered Dead/Abandoned |
Biotech Incorporated 2015-04-01 |
CRYOLOCK 86583643 not registered Dead/Abandoned |
Biotech Incorporated 2015-04-01 |