Biosign Biological Indicator (Eight Month Exp.)
FDA 510(k) K891366 · Mdt Corp., Inc.
510(k) numberK891366
Submission
- Device name
- Biosign Biological Indicator (Eight Month Exp.)
- Applicant
- Mdt Corp., Inc.
Rochester, NY, US - Received
- March 3, 1989
- Decision date
- March 29, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRC – Indicator, Biological Sterilization Process
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
Other 510(k)s with product code FRC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260766 | Celerity 5 HP Biological Indicator (LCB052)FRC · Special | STERIS Corporation | 04/08/2026SE |
| K252680 | Celerity 20 HP Biological IndicatorFRC · Special | STERIS Corporation | 09/24/2025SE |
| K251122 | Terragene® Bionova® BT20 Biological IndicatorFRC · Traditional | Terragene | 08/04/2025SE |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | Steris | 06/06/2025SE |
| K250061 | Celerity IncubatorFRC · Special | STERIS Corporation | 02/06/2025SE |
| K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | STERIS Corporation | 02/06/2025SE |
| K243501 | 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest…FRC · Traditional | 3M Company | 01/28/2025SE |
| K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator…FRC · Traditional | Terragene S.A. | 12/12/2024SE |
| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 3M Company | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 3M Company | 10/18/2024SE |
More from 3M Company
| 510(k) | Device | Decision |
|---|---|---|
| K960777 | MDT Unispore and Spor-Test BiologicalindicatorFRC · Traditional | 05/23/1996SE |
| K942485 | MDT Urology TableMMZ · Traditional | 08/26/1994SE |
| K942486 | Image Full Power Examination/Minor Surgery TableFQO · Traditional | 08/10/1994SE |
| K924380 | Mdt/Harvey Model 7000 & 8000 ChemiclaveMLR · Traditional | 02/16/1994SE |
| K926081 | Dental LightEAZ · Traditional | 01/26/1994SE |
| K924955 | Mdt/Harvey MC-8 and MC-10FLE · Traditional | 10/15/1993SE |
| K932094 | Bovie Ultrasonic Surgical AspiratorLFL · Traditional | 07/21/1993SE |
| K931169 | MDT Dental ChairKLC · Traditional | 05/20/1993SE |
| K920930 | Mdt/Castle 10/90 Dual Load StationFLF · Traditional | 03/31/1993SE |
| K922212 | MDT Castle Biosign Test PackFRC · Traditional | 08/10/1992SE |
Questions and answers
When was Biosign Biological Indicator (Eight Month Exp.) cleared by the FDA?
Biosign Biological Indicator (Eight Month Exp.) (K891366) received a 510(k) decision of Substantially Equivalent on March 29, 1989, 26 days after the submission was received.
What is the product code of K891366?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.