IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT
FDA 510(k) clearance K882674 · decided 1989-08-15
Clearance details
- K-number
- K882674
- Device name
- IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT
- Applicant
- Icn Immunobiologicals
- Decision
- Substantially Equivalent
- Date received
- 1988-06-28
- Decision date
- 1989-08-15
- Days to decision
- 413 days
- Clearance type
- Traditional
- Product code
- LKH
- Device class
- 1
- Regulation number
- 866.3120
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Lisle, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IPAZYME (TM) CHLAMYDIA IGG-IGA (K910644) | Savyon Diagnostics , Ltd. | 1991-03-19 |
| IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) (K901975) | Savyon Diagnostics , Ltd. | 1991-03-08 |
| CELLMATICS SHLAMYDIA DETECTION SYSTEM (K893669) | Difco Laboratories, Inc. | 1989-06-23 |
| SELECTICULT-CHLAMYDIA (K852869) | Scott Laboratories, Inc. | 1985-09-19 |
| CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT (K842151) | Bartels Immunodiagnostic Supplies, Inc. | 1984-07-20 |
| COMBION SKIN TEST (K830688) | Nicholas H. Maganias | 1983-03-31 |
| HISTOSET IMMUNOPEROXIDASE TISSURE KIT (K820390) | Immulok, Inc. | 1982-04-14 |
Recalls involving this device
No recalls on record reference this clearance.