Company ยท US
Reagent Laboratory, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1986. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | 3 |
| JJO | Flame Emission Photometer For Clinical Use | 3 |
| GGK | Products, Red-Cell Lysing Products | 2 |
| JGS | Electrode, Ion Specific, Sodium | 2 |
| FNW | Pad, Kelly | 1 |
| GIF | Diluent, Blood Cell | 1 |
| IFP | Formalin, Neutral Buffered | 1 |
| JCC | Ph Buffer | 1 |
| JJP | Electrode, Ion Selective (Non-Specified) | 1 |
| JTS | Stains, Microbiologic | 1 |
| KFC | Methylene Blue, Tissue Stain | 1 |
| PPM | General Purpose Reagent | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 1986 | K863502 | SOLUTION B- NA 50MEQ/L, K 40 MEQ/L Reagent Laboratory, Inc. | JIX |
| Oct 3, 1986 | K863503 | HEMOLYSE Reagent Laboratory, Inc. | GGK |
| Oct 2, 1986 | K863550 | POTASSIUM HYDROXIDE 10% W/V Reagent Laboratory, Inc. | PPM |
| Feb 10, 1986 | K860143 | URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE Reagent Laboratory, Inc. | JJP |
| Oct 1, 1984 | K842982 | FORMALIN BUFFERED Reagent Laboratory, Inc. | IFP |
| Sep 11, 1984 | K843050 | GRAM STAIN Reagent Laboratory, Inc. | JTS |
| Sep 11, 1984 | K842785 | STAIN, METHYLENE BLUE-EOSIN Reagent Laboratory, Inc. | KFC |
| Aug 17, 1984 | K841847 | LITHIUM REAGENT Reagent Laboratory, Inc. | JJO |
| Aug 3, 1984 | K843051 | WRIGHTS STAIN SOLUTION Reagent Laboratory, Inc. | |
| May 31, 1984 | K841800 | LYSING & HEMOGLOBIN REAGENT Reagent Laboratory, Inc. | GGK |
| May 31, 1984 | K841799 | CYANOMETHEMOGLOBIN REAGENT Reagent Laboratory, Inc. | GIF |
| May 22, 1984 | K841423 | SCOTTS TAP WATER SUBSTITUTE 7 Reagent Laboratory, Inc. | JCC |
| May 21, 1984 | K841183 | SODIUM CHLORIDE SOLUTION BLOOD CELL Reagent Laboratory, Inc. | FNW |
| May 16, 1984 | K841418 | SODIUM ELECTRODE RINSE SOLUTION 2 Reagent Laboratory, Inc. | JGS |
| May 16, 1984 | K841417 | POTASSIUM CHLORIDE SOLUTION -2 MOLAR Reagent Laboratory, Inc. | JGS |
| May 11, 1984 | K841422 | VOLUME TEST DYE 6 Reagent Laboratory, Inc. | JJO |
| May 11, 1984 | K841421 | DAILY WASH SOLUTION 5 Reagent Laboratory, Inc. | JJO |
| May 11, 1984 | K841420 | SODIUM & POTASSIUM STANDARD SOL 80 Reagent Laboratory, Inc. | JIX |
| May 11, 1984 | K841419 | SODIUM & POTASSIUM STANDARD SOLUT Reagent Laboratory, Inc. | JIX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||