510(k) K780713
- Device
- CULTURE SWAB
- Applicant
- ROYAL SCIENTIFIC, INC.
- 510(k) number
- K780713
- Product code
- JRW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-05-12
- Date received
- 1978-04-27
- Regulation
- 866.3065
- Classification name
- Antisera, Fluorescent, B. Parapertussis
- 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
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JRW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K761019 | PIPETTER-DILUTER (MODEL 273) | Beckman Instruments, Inc. | 1976-11-16 |
Legacy Summary#
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FDA Review#
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