510(k) K760833
- Device
- ANTI-BLASTOMYCES CONTROL SERUM (YEAST)
- Applicant
- I M, INC.
- 510(k) number
- K760833
- Product code
- KFH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-11-01
- Date received
- 1976-10-13
- Regulation
- 866.3060
- Classification name
- Antiserum, Positive Control, Blastomyces Dermatitidis
- Medical specialty
- Microbiology
- 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#
- 3043106343
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KFH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K880029 | EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 | Immuno-Mycologics, Inc. | 1988-02-24 |
| K792681 | BLASTOMYCES DERMATITIDIS POS/CONTROL | Meridian Diagnostics, Inc. | 1980-01-17 |
| K792685 | BLASTOMYCES DERMATITIDIS, ANTISERUM | Meridian Diagnostics, Inc. | 1980-01-17 |
Legacy Summary#
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FDA Review#
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