Hycel, Inc.
Mchenry, IL, US
Hycel, Inc. appears in FDA device records in Mchenry, IL. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Hycel, Inc. between 1976 and 1980. The busiest year on record is 1977, with 9. The most recent is 1980, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 9 |
| 1978 | 5 |
| 1979 | 3 |
| 1980 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K802422 | HYCEL TRIGYCERIDE II TEST | Unknown | ||
| K790335 | HYCEL M | JJF | Substantially Equivalent | |
| K782176 | HYCEL LDH-INT TEST | CFH | Substantially Equivalent | |
| K782116 | KETOSTEROID TEST, HYCEL-17 | CCY | Substantially Equivalent | |
| K781004 | HMA URIC ACID TEST | KNK | Substantially Equivalent | |
| K780946 | ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER | JPJ | Substantially Equivalent | |
| K780464 | LELECTIVE KINETIC SYSTEM-60 | JJE | Substantially Equivalent | |
| K780262 | DIRECT UREA NITROGEN TEST | CDW | Substantially Equivalent | |
| K772426 | 17-HYDROXY TEST | CDB | Substantially Equivalent | |
| K771259 | ALBUMIN TEST, HMA ALBUMIN TEST | CIX | Substantially Equivalent | |
| K771353 | PLATELET COUNTER & HEMATOCRIT ACCES. | GKL | Substantially Equivalent | |
| K771343 | LDH-INT TEST | CFH | Substantially Equivalent | |
| K771154 | CPK-INT TEST | Substantially Equivalent | ||
| K771107 | COUNTER 700 & HC-700 HEMO 0 REF. | GKL | Substantially Equivalent | |
| K770803 | HEMOTOLOGY PRODU&TS (5 IN ALL) | GKK | Substantially Equivalent | |
| K770643 | CREATININE TEST, SUPER SEVENTEEN | CGX | Substantially Equivalent | |
| K770748 | TEST, FERROZINE IRON & IRON BINDING | JMO | Substantially Equivalent | |
| K770393 | PROPANE, HIGH PURITY, INSTRUMENT GRADE | JJO | Substantially Equivalent | |
| K760468 | TEST, REFORMULATED HYCEL HMA CALCIUM | CIC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNKAcid, Uric, Uricase (Colorimetric)
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- JJFAnalyzer, Chemistry, Micro, For Clinical Use
- CIXBromcresol Green Dye-Binding, Albumin
- GKLCounter, Cell, Automated (Particle Counter)
- CICCresolphthalein Complexone, Calcium
- GKKCyanomethemoglobin
- CDWDiacetyl-Monoxime, Urea Nitrogen
- JMOFerrozine (Colorimetric) Iron Binding Capacity
- JJOFlame Emission Photometer For Clinical Use
- CDBPorter Silber Hydrazone, 17-Hydroxycorticosteroids
- JPJRed-Cell Indices, Calculated
- CFHTetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
- CCYZimmerman (Spectrophotometric), 17-Ketosteroids
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain