Device Classification Name |
Dna Probe, Nucleic Acid Amplification, Chlamydia
|
510(k) Number |
K962217 |
Device Name |
GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT |
Applicant |
GEN-PROBE, INC. |
9880 CAMPUS POINT DR. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
GERALD H SCHELL |
Correspondent |
GEN-PROBE, INC. |
9880 CAMPUS POINT DR. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
GERALD H SCHELL |
Regulation Number | 866.3120
|
Classification Product Code |
|
Date Received | 06/10/1996 |
Decision Date | 11/27/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|