510(k) K210481
- Device
- Instant 20s Indicator
- Applicant
- True Indicating, LLC
- 510(k) number
- K210481
- Product code
- MTC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-12-14
- Date received
- 2021-02-19
- Regulation
- 880.2800
- Classification name
- Indicator, Chemical, Enzymatic, Sterilization Process
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Thomas Riha
- Address
- 946 Kane St. Toledo OH US 43612 43612
FDA Registration Numbers#
- 8030087
- 3017524825
Source Documents#
Other 510(k) Records For Product Code MTC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K962649 | SPORTROL RAPID STERILITY INDICATOR | North American Science Assoc., Inc. | 1997-09-26 |