PPM
16 FDA 510(k) clearances · Product code
29 daysmedian time to decision
70 days90th percentile
16clearances measured
FDA profile
- Official device name
- General Purpose Reagent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.4010
- Medical specialty
- Pathology
- Flags
- GMP exempt
- FDA definition
- A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.
- Adverse events (MAUDE)
- 2017: 10 · 2022: 31 · 2025: 230
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 |
|---|---|---|
| TOMTEC GRAM STAINER DECOLORIZER (K871533) | Remel Co. | 1987-04-29 |
| POTASSIUM HYDROXIDE 10% W/V (K863550) | Reagent Laboratory, Inc. | 1986-10-02 |
| 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2 (K861890) | Richard-Allan Medical Ind., Inc. | 1986-06-03 |
| SPRAYFIX (K850916) | Surgipath Medical Industries, Inc. | 1985-03-25 |
| TRANSPORT CULTURE MEDIUM (K850737) | Roseville Medical Laboratoriesu | 1985-03-20 |
| 0.85% SALINE (K850845) | Micro Media Laboratories | 1985-03-20 |
| DECOLORIZING FLUIC, ACID-ALCOHOL 3% (K842934) | E K Ind., Inc. | 1984-09-12 |
| PRO-SOFT DEHYDRANT (K842863) | Anatech, Ltd. | 1984-08-21 |
| DECOLORIZING FLUID (K842729) | E K Ind., Inc. | 1984-08-03 |
| IDD DETERGENT (K842070) | Interscience Diagnostics, Inc. | 1984-07-02 |
| SODIUM HYPOCHLORITE 3% (K831620) | Omega Medical Diagnostics | 1983-07-28 |
| SODIUM HYPOCHLORITE 7% (K831619) | Omega Medical Diagnostics | 1983-07-28 |
| BLENDED DETERGENT-78N 1912-1 (K822326) | Interscience, Inc. | 1982-10-18 |
| VOLU-SOL TAP WATER SUBSTITUTE (K822037) | Volu Sol Medical Industries | 1982-08-03 |
| BLUING REAGENT (K811800) | Richard-Allan Medical Ind., Inc. | 1981-08-12 |
| FORMAL ALCOHOL (K811796) | Richard-Allan Medical Ind., Inc. | 1981-07-28 |
Track PPM automatically
Every clearance here is in the API, with alerts when new ones post.