510(k) K812189
- Device
- COCCIDIOIDES LATEX AGGLUTINATION
- Applicant
- AMERICAN SCIENTIFIC PRODUCTS
- 510(k) number
- K812189
- Product code
- GMG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-08-25
- Date received
- 1981-08-03
- Regulation
- 866.3135
- Classification name
- Antigen, Latex Agglutination, Coccidioides Immitis
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1524213
- 1627497
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GMG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K792690 | COCCIDIOIDES IMMITIS, LATEX AGGLUTI | Meridian Diagnostics, Inc. | 1980-01-17 |
| K791381 | COCCIDIODES (COCCI) | Immuno-Mycologics, Inc. | 1979-08-16 |
| K782070 | REAGENT, COCCI LATEX | I M, Inc. | 1979-02-01 |
| K760829 | COCCIDIOIDES MYCELIAL ANTIGEN | I M, Inc. | 1976-11-01 |
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