510(k) K811138
- Device
- Nutrient Agar
- Applicant
- ACUMEDIA MANUFACTURERS, INC.
- 510(k) number
- K811138
- Product code
- JSQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-05-05
- Date received
- 1981-04-24
- Regulation
- 862.2250
- Classification name
- Chromatography For Bacterial Identification
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- 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