LITHIUM REAGENT
FDA 510(k) clearance K841847 · decided 1984-08-17
Clearance details
- K-number
- K841847
- Device name
- LITHIUM REAGENT
- Applicant
- Reagent Laboratory, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-04-18
- Decision date
- 1984-08-17
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- JJO
- Device class
- 1
- Regulation number
- 862.2540
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Reagent Laboratory
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FINNIGAN MAT INCOS 50 (K873603) | Finnigan Corp. | 1987-09-22 |
| OLYMPUS AU 5000 FLAME PHOTOMETER MODULE (K862148) | Olympus Corp. | 1986-09-29 |
| ELVI 655 FLAME PHOTOMETER (K843375) | Logos Scientific, Inc. | 1985-05-20 |
| FLAME PHOTOMETERS (K834226) | Dr. Bruno Lange GmbH | 1984-06-22 |
| DAILY WASH SOLUTION 5 (K841421) | Reagent Laboratory, Inc. | 1984-05-11 |
| VOLUME TEST DYE 6 (K841422) | Reagent Laboratory, Inc. | 1984-05-11 |
| SUPPLIES FOR INSTRUMENTATION LAB FLAME (K840530) | Shaban Mfg. Co. | 1984-03-30 |
| SDI PREPAX DILUKIT 29-1000 (K840044) | Scientific Distributors, Inc. | 1984-03-09 |
| POTASSIUM SODIUM ANALYSIS PRODUCTS (K833535) | Shaban Mfg. Co. | 1983-12-29 |
| FLAME PHOTOMETER T281-T282-T283 (K832886) | Texas Intl. Laboratories, Inc. | 1983-12-08 |
| SHABAN #9868 TUBING KIT-9870 STYLET (K832937) | Shaban Mfg. Co. | 1983-10-14 |
| SHABAN #9858 ASPIRATOR ASSEMBLE #9862- (K832932) | Shaban Mfg. Co. | 1983-10-14 |
Recalls involving this device
No recalls on record reference this clearance.