510(k) K832575
- Device
- ANTIBIOTIC ASSAY BROTH
- Applicant
- ACUMEDIA MANUFACTURERS, INC.
- 510(k) number
- K832575
- Product code
- JSA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-09-12
- Date received
- 1983-08-02
- Regulation
- 866.2350
- Classification name
- Culture Media, Antibiotic Assay
- Medical specialty
- Microbiology
- 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
FDA Registration Numbers#
- 3017871324
- 3008264111
- 3005182157
- 8010096
- 3015715780
- 3015495690
- 3005182159
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JSA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K881534 | ANTIBIOTIC MEDIUM #9 POLYMYXIN BASE AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881535 | ANTIBIOTIC MEDIUM #6 | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881536 | ANTIBIOTIC MEDIUM #5 STREPTOMYCIN ASSAY AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881537 | ANTIBIOTIC MEDIUM #19 | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881538 | ANTIBIOTIC MEDIUM #10 POLYMYXIN SEED AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K832576 | BASE AGAR | Acumedia Manufacturers, Inc. | 1983-09-12 |
| K832577 | SEED AGAR | Acumedia Manufacturers, Inc. | 1983-09-12 |
Legacy Summary#
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FDA Review#
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