510(k) K862184
- Device
- DAKO ITA, IMMUNOGLOBULIN M (IGM)
- Applicant
- DAKO CORP.
- 510(k) number
- K862184
- Product code
- DAH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-08-19
- Date received
- 1986-06-09
- Regulation
- 866.5510
- Classification name
- Gamma Globulin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BROOKS, PH.D.
- Address
- 22 N. Milpas St. Santa Barbara CA US 93103 93103
FDA Registration Numbers#
- 1618982
- 9610126
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DAH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K931247 | TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 | Helena Laboratories | 1993-04-27 |
| K905149 | TITAN GEL | Helena Laboratories | 1991-01-03 |
| K901805 | REP(R) IMMUNOFIX | Helena Laboratories | 1990-06-06 |
| K884074 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G | Orion Diagnostica, Inc. | 1988-10-27 |
| K883494 | TECHNICON DPA-1 IMMUNOGLOBULIN G | Technicon Instruments Corp. | 1988-09-07 |
| K854944 | TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT | Abbott Laboratories | 1986-08-27 |
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