510(k) K820390
- Device
- HISTOSET IMMUNOPEROXIDASE TISSURE KIT
- Applicant
- IMMULOK, INC.
- 510(k) number
- K820390
- Product code
- LKH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-04-14
- Date received
- 1982-02-10
- Regulation
- 866.3120
- Classification name
- Antisera, Immunoperoxidase, Chlamydia Spp.
- Medical specialty
- Microbiology
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LKH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K910644 | IPAZYME (TM) CHLAMYDIA IGG-IGA | Savyon Diagnostics , Ltd. | 1991-03-19 |
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases