510(k) K910644
- Device
- IPAZYME (TM) CHLAMYDIA IGG-IGA
- Applicant
- SAVYON DIAGNOSTICS, LTD.
- 510(k) number
- K910644
- Product code
- LKH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-03-19
- Date received
- 1991-02-14
- Regulation
- 866.3120
- Classification name
- Antisera, Immunoperoxidase, Chlamydia Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- EMMANUEL A ROSEN
- Address
- Kiryat Minrav Habosem 3, Ashdod IL 77101 77101
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LKH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K901975 | IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) | Savyon Diagnostics , Ltd. | 1991-03-08 |
| K882674 | IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT | Icn Immunobiologicals | 1989-08-15 |
| K893669 | CELLMATICS SHLAMYDIA DETECTION SYSTEM | Difco Laboratories, Inc. | 1989-06-23 |
| K852869 | SELECTICULT-CHLAMYDIA | Scott Laboratories, Inc. | 1985-09-19 |
| K842151 | CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT | Bartels Immunodiagnostic Supplies, Inc. | 1984-07-20 |
| K830688 | COMBION SKIN TEST | Nicholas H. Maganias | 1983-03-31 |
| K820390 | HISTOSET IMMUNOPEROXIDASE TISSURE KIT | Immulok, Inc. | 1982-04-14 |
Legacy Summary#
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FDA Review#
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