510(k) K812194
- Device
- IMMUNODIFFUSION BAND INTENSIFYING FLUID
- Applicant
- AMERICAN SCIENTIFIC PRODUCTS
- 510(k) number
- K812194
- Product code
- JZS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-08-31
- Date received
- 1981-08-03
- Regulation
- 866.4500
- Classification name
- Electrophoresis Instrumentation
- Medical specialty
- Immunology
- Review panel
- Microbiology
- 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 JZS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K933123 | SYNELISA TG ANTIBODIES/TPO ANTIBODIES | Elias U.S.A., Inc. | 1993-08-23 |
| K770566 | IMMUNOELECTROPHORESIS PROFILE KIT | Kallestad Laboratories, Inc. | 1977-04-27 |
| K770718 | STAIN, R-250, COOMASSIE BRILLIANT BLUE | Kallestad Laboratories, Inc. | 1977-04-26 |
| K770719 | IMMUNOELECTROFILM KIH | Kallestad Laboratories, Inc. | 1977-04-26 |
| K770150 | ELECTRO IMMUNO ASSAY KIT | Millipore Corp. | 1977-02-01 |
Legacy Summary#
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FDA Review#
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