Company ยท US
Harleco Diagnostics
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1982. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 2 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 2 |
| CDO | Acid, Uric, Uricase (U.V.) | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CEX | Chromatographic Separation, Lactate Dehydrogenase Isoenzymes | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| JFJ | Catalytic Methods, Amylase | 1 |
| JIS | Calibrator, Primary | 1 |
| JIT | Calibrator, Secondary | 1 |
| JMK | Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase | 1 |
| JPZ | Colorimetric Method, Gamma-Glutamyl Transpeptidase | 1 |
| LFR | Glucose Dehydrogenase, Glucose | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 22, 1982 | K823147 | URIC ACID STANDARD, 8MG/DL #65078 Harleco Diagnostics | JIS |
| Oct 27, 1982 | K822852 | TRIGLYCERIDE CALIBRATOR Harleco Diagnostics | JIT |
| Sep 2, 1982 | K822323 | ULTRACHEM BUN-UV, 65080 & 65081 Harleco Diagnostics | CDW |
| Jul 14, 1982 | K821883 | ULTRAZYME PLUS CK-I Harleco Diagnostics | CGS |
| Jul 14, 1982 | K821882 | ULTRAZYME PLUS GPT Harleco Diagnostics | CKA |
| Jul 14, 1982 | K821881 | ULTRACHEM CREA Harleco Diagnostics | CGX |
| Jul 14, 1982 | K821880 | ULTRA CHEM ALB Harleco Diagnostics | CIX |
| Jul 14, 1982 | K821879 | ULTRACHEM T.P. Harleco Diagnostics | CEX |
| Jul 14, 1982 | K821878 | ULTRAZYME PLUS LDH Harleco Diagnostics | CFJ |
| Jul 14, 1982 | K821877 | ULTRAZYME PLUS HBD Harleco Diagnostics | JMK |
| Jul 14, 1982 | K821873 | ULTRACHEM T-BILI Harleco Diagnostics | CIG |
| Jul 14, 1982 | K821872 | ULTRACHEM URIC ACID AIDH Harleco Diagnostics | CDO |
| Jul 14, 1982 | K821871 | ULTRAZYME PLUS 2GT Harleco Diagnostics | JPZ |
| Jul 13, 1982 | K821876 | ULTRAZYME PLUS GOT Harleco Diagnostics | CIT |
| Jul 13, 1982 | K821875 | ULTRACHEM TRI-ES Harleco Diagnostics | CDT |
| Jul 13, 1982 | K821874 | ULTRACHEM PHOS Harleco Diagnostics | CEO |
| Jul 13, 1982 | K821870 | ULTRAZYME PLUS ALP Harleco Diagnostics | CJE |
| Jul 13, 1982 | K821869 | ULTRAZYME PLUS AMYL Harleco Diagnostics | JFJ |
| Jul 8, 1982 | K821868 | ULTRACHEM E-GLU Harleco Diagnostics | CFR |
| Jul 6, 1982 | K821867 | ULTRACHEM GLUC-DH Harleco Diagnostics | LFR |
| Jul 1, 1977 | K770694 | CPK ULTRAZYME PLUS Harleco Diagnostics | CGS |
| Jun 17, 1977 | K770613 | LDH ULTRAZYME PLUS Harleco Diagnostics | CFJ |
| Nov 30, 1976 | K761026 | AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL Harleco Diagnostics | CIX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||