LKH — Antisera, Immunoperoxidase, Chlamydia Spp. Class I
FDA Device Classification
Classification Details
- Product Code
- LKH
- Device Class
- Class I
- Regulation Number
- 866.3120
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K910644 | savyon diagnostics | IPAZYME (TM) CHLAMYDIA IGG-IGA | March 19, 1991 |
| K901975 | savyon diagnostics | IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) | March 8, 1991 |
| K882674 | icn immunobiologicals | IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT | August 15, 1989 |
| K893669 | difco laboratories | CELLMATICS SHLAMYDIA DETECTION SYSTEM | June 23, 1989 |
| K852869 | scott laboratories | SELECTICULT-CHLAMYDIA | September 19, 1985 |
| K842151 | bartels immunodiagnostic supplies | CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT | July 20, 1984 |
| K830688 | nicholas h. maganias | COMBION SKIN TEST | March 31, 1983 |
| K820390 | immulok | HISTOSET IMMUNOPEROXIDASE TISSURE KIT | April 14, 1982 |