510(k) K883494
- Device
- TECHNICON DPA-1 IMMUNOGLOBULIN G
- Applicant
- TECHNICON INSTRUMENTS CORP.
- 510(k) number
- K883494
- Product code
- DAH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-09-07
- Date received
- 1988-08-16
- 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
- LEONARD A DWARICA
- Address
- 511 Benedict Ave. Tarrytown NY US 10591 10591
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 |
| K854944 | TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT | Abbott Laboratories | 1986-08-27 |
| K862184 | DAKO ITA, IMMUNOGLOBULIN M (IGM) | Dako Corp. | 1986-08-19 |
Legacy Summary#
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FDA Review#
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