K822504 is an FDA 510(k) clearance for the CDL AUTO-LYSING REAGENT. This device is classified as a Products, Red-cell Lysing Products (Class I - General Controls, product code GGK).
Submitted by Connecticut Diagnostics, Ltd. (Mchenry, US). The FDA issued a Cleared decision on September 17, 1982, 29 days after receiving the submission on August 19, 1982.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8540.
| 510(k) Number | K822504 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 1982 |
| Decision Date | September 17, 1982 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GGK — Products, Red-cell Lysing Products |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.8540 |