LRH
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Instrument For Auto Reader Of Overnight Microorganism Identification System
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 2000: 9 · 2001: 6 · 2002: 9 · 2003: 5 · 2004: 5 · 2005: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GRAM NEGATIVE IDENTIFICATION PLUS CARD (K962609) | Biomerieux Vitek, Inc. | 1996-08-30 |
| MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL (K961042) | Dade Microscan, Inc. | 1996-05-30 |
| READER (K926248) | Alamar Biosciences Laboratory, Inc. | 1994-05-17 |
| AUTOSCEPTOR IDENTIFICATION SYSTEM (K920225) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-05-22 |
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Every clearance here is in the API, with alerts when new ones post.