510(k) K790430
- Device
- MEDICA II-F-ASMA TEST KIT
- Applicant
- MEDICA CORP.
- 510(k) number
- K790430
- Product code
- DBE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-04-23
- Date received
- 1979-03-02
- Regulation
- 866.5120
- Classification name
- Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- 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#
- 3022178699
- 2029372
- 2242436
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DBE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K810983 | ANTISMOOTH MUSCLE ANTIBODY TEST SYS | Immuno-Products Industries | 1981-05-01 |
| K800820 | AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY | Calbiochem-Behring Corp. | 1980-04-24 |
| K800228 | IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT | Clinical Sciences, Inc. | 1980-02-21 |
| K771155 | ANTI-MITOCHONDRIAL | Meloy Laboratories, Inc. | 1977-08-04 |
| K760156 | TEST, (IVDP) SMOOTHMUSCLE ANTIBODY | Zeus Scientific, Inc. | 1976-07-20 |
Legacy Summary#
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FDA Review#
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