510(k) K771155
- Device
- ANTI-MITOCHONDRIAL
- Applicant
- Meloy Laboratories, Inc.
- 510(k) number
- K771155
- Product code
- DBE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-08-04
- Date received
- 1977-06-28
- 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
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3022178699
- 2242436
- 2029372
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 |
| K790430 | MEDICA II-F-ASMA TEST KIT | Medica Corp. | 1979-04-23 |
| K760156 | TEST, (IVDP) SMOOTHMUSCLE ANTIBODY | Zeus Scientific, Inc. | 1976-07-20 |