LKH
8 FDA 510(k) clearances · Product code
63 daysmedian time to decision
413 days90th percentile
8clearances measured
FDA profile
- Official device name
- Antisera, Immunoperoxidase, Chlamydia Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3120
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| 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 |
| IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT (K882674) | Icn Immunobiologicals | 1989-08-15 |
| 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 |
Track LKH automatically
Every clearance here is in the API, with alerts when new ones post.