Sandare Chemical Co., Inc.
Mchenry, IL, US
Sandare Chemical Co., Inc. appears in FDA device records in Mchenry, IL. FDA records list 23 510(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
- 23
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 23 510(k) clearances for Sandare Chemical Co., Inc. between 1979 and 1987. The busiest year on record is 1980, with 4. The most recent is 1987, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 3 |
| 1980 | 4 |
| 1981 | 4 |
| 1983 | 4 |
| 1984 | 3 |
| 1985 | 2 |
| 1986 | 2 |
| 1987 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K872852 | EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST | LCP | Substantially Equivalent | |
| K862556 | SANDARE GLYCOHEMOGLOBIN PROCEDURE | LCP | Substantially Equivalent | |
| K860684 | SANDARE BCG ALBUMIN PROCEDURE | CIX | Substantially Equivalent | |
| K851395 | SANDARE IRON-BINDING CAPACITY PROCEDURE | JMO | Substantially Equivalent | |
| K851394 | SANDARE IRON PROCEDURE | JIY | Substantially Equivalent | |
| K844498 | SANDARE ALKALINE PHOSPHATASE PROCEDURE | CIO | Substantially Equivalent | |
| K842516 | SANDARE ACID PHOSPHATASE PROCEDURE | CJR | Substantially Equivalent | |
| K833898 | TRI-LEVEL BILIRUBIN CONTROLS | JJX | Substantially Equivalent | |
| K832942 | TOTAL & DIRECT BILIRUBIN PROCEDURES | CIG | Substantially Equivalent | |
| K832632 | ALBUMIN PROCEDURE BCP | CJW | Substantially Equivalent | |
| K832183 | SANDARE CALCIUM PROCEDURE | CIC | Substantially Equivalent | |
| K832169 | TOTAL PROTEIN PROCEDURE | CEK | Substantially Equivalent | |
| K812670 | SANDARE FAST 340 PHOSPHORUS PROCEDURE | CED | Substantially Equivalent | |
| K812313 | SANDARE URIC ACID PROCEDURE | LFQ | Substantially Equivalent | |
| K810514 | SANDARE NITROPRUSSIDE TEST PROCEDURE | JLC | Substantially Equivalent | |
| K802832 | SANDARE GLYCOHEMOGLOBIN PROCEDURE | LCP | Substantially Equivalent | |
| K801422 | SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS. | LCP | Substantially Equivalent | |
| K800780 | SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS | JPK | Substantially Equivalent | |
| K800297 | SANDARE FAST 340 PHOSPHOROUS PROCEDURE | CEO | Substantially Equivalent | |
| K792531 | SANDARE CHLORIDE PROCEDURE | CHJ | Substantially Equivalent | |
| K792503 | SANDARE CYANMETHEMOGLOBIN REAGENT | KHG | Substantially Equivalent | |
| K792358 | SANDARE CYANMETHEMOGLOBIN STANDARD | KRZ | Substantially Equivalent | |
| K792209 | SANDARE HEMOGLOBIN CONTROLS | JPK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CED5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
- CJRAcid Phosphatase, Thymol Blue Monophosphate
- LFQAcid, Uric, Acid Reduction Of Ferric Ion
- LCPAssay, Glycosylated Hemoglobin
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- CJWBromcresol Purple Dye-Binding, Albumin
- KRZCalibrator For Hemoglobin And Hematocrit Measurement
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- JMOFerrozine (Colorimetric) Iron Binding Capacity
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- JPKMixture, Hematology Quality Control
- JLCNitroprusside Reaction (Qualitative, Urine), Cystine
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- CIOThymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
- KHGWhole Blood Hemoglobin Determination
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