Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessionum63giq7mdjld6csnbi0hih57d4lhfe2): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pmn.php
Line: 8
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pmn_item.php
Line: 11
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_session4ucf6uqh8c07sms5o5e201kc49oj7a01): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pmn.php
Line: 8
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pmn_item.php
Line: 11
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessionkmjld2mqrp84o0i6ns4lc2j7g6nrgpqg): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pmn.php
Line: 8
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pmn_item.php
Line: 11
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessionas88q0ocs44h578k6lebrktbblmn9oh6): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pmn.php
Line: 8
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pmn_item.php
Line: 11
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessiongd1ssqecqal0j6mso9flsm6qtu4q882a): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pmn.php
Line: 8
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pmn_item.php
Line: 11
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessionodq3ueimge4vibcuk2fq2ltin9kmqaks): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pmn.php
Line: 8
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pmn_item.php
Line: 11
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_session5pf9r824nk96hfj9lvqad6uv1c5r1h2j): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pmn.php
Line: 8
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pmn_item.php
Line: 11
Function: include
The following data is part of a premarket notification filed by Harleco Diagnostics with the FDA for Ultrazyme Plus Ck-i.
| Device ID | K821883 |
| 510k Number | K821883 |
| Device Name: | ULTRAZYME PLUS CK-I |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | HARLECO DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-25 |
| Decision Date | 1982-07-14 |