510(k) K863122
- Device
- ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.
- Applicant
- SURGICOT, INC.
- 510(k) number
- K863122
- Product code
- FRC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-12-17
- Date received
- 1986-08-14
- Regulation
- 880.2800
- Classification name
- Indicator, Biological Sterilization Process
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code FRC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260766 | Celerity 5 HP Biological Indicator (LCB052) | STERIS Corporation | 2026-04-08 |
| K252680 | Celerity™ 20 HP Biological Indicator | STERIS Corporation | 2025-09-24 |
| K251122 | Terragene® Bionova® BT20 Biological Indicator | Terragene | 2025-08-04 |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | Steris | 2025-06-06 |
| K250061 | Celerity Incubator | STERIS Corporation | 2025-02-06 |
| K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | STERIS Corporation | 2025-02-06 |
| K243501 | 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M | 3M Company | 2025-01-28 |
| K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) | Terragene S.A. | 2024-12-12 |
| K242538 | 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M | 3M Company | 2024-11-25 |
| K241959 | 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M) | 3M Company | 2024-10-18 |
| K231383 | Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) | Terragene S.A. | 2024-09-18 |
| K241710 | 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M | 3M Company | 2024-09-12 |
| K241542 | 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) | 3M Company | 2024-06-27 |
| K240717 | 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Company | 2024-06-27 |
| K233814 | 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M) | 3M Company | 2024-03-15 |
Legacy Summary#
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FDA Review#
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