Company ยท US
Sandare Chemical Co., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 1987. 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 |
|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | 4 |
| JPK | Mixture, Hematology Quality Control | 2 |
| CED | 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| CIO | Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CJR | Acid Phosphatase, Thymol Blue Monophosphate | 1 |
| CJW | Bromcresol Purple Dye-Binding, Albumin | 1 |
| JIY | Photometric Method, Iron (Non-Heme) | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
| JLC | Nitroprusside Reaction (Qualitative, Urine), Cystine | 1 |
| JMO | Ferrozine (Colorimetric) Iron Binding Capacity | 1 |
| KHG | Whole Blood Hemoglobin Determination | 1 |
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | 1 |
| LFQ | Acid, Uric, Acid Reduction Of Ferric Ion | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 29, 1987 | K872852 | EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST Sandare Chemical Co., Inc. | LCP |
| Aug 8, 1986 | K862556 | SANDARE GLYCOHEMOGLOBIN PROCEDURE Sandare Chemical Co., Inc. | LCP |
| Mar 17, 1986 | K860684 | SANDARE BCG ALBUMIN PROCEDURE Sandare Chemical Co., Inc. | CIX |
| May 7, 1985 | K851395 | SANDARE IRON-BINDING CAPACITY PROCEDURE Sandare Chemical Co., Inc. | JMO |
| Apr 30, 1985 | K851394 | SANDARE IRON PROCEDURE Sandare Chemical Co., Inc. | JIY |
| Dec 10, 1984 | K844498 | SANDARE ALKALINE PHOSPHATASE PROCEDURE Sandare Chemical Co., Inc. | CIO |
| Aug 17, 1984 | K842516 | SANDARE ACID PHOSPHATASE PROCEDURE Sandare Chemical Co., Inc. | CJR |
| Jan 13, 1984 | K833898 | TRI-LEVEL BILIRUBIN CONTROLS Sandare Chemical Co., Inc. | JJX |
| Nov 7, 1983 | K832942 | TOTAL & DIRECT BILIRUBIN PROCEDURES Sandare Chemical Co., Inc. | CIG |
| Sep 12, 1983 | K832632 | ALBUMIN PROCEDURE BCP Sandare Chemical Co., Inc. | CJW |
| Aug 24, 1983 | K832183 | SANDARE CALCIUM PROCEDURE Sandare Chemical Co., Inc. | CIC |
| Aug 16, 1983 | K832169 | TOTAL PROTEIN PROCEDURE Sandare Chemical Co., Inc. | CEK |
| Oct 2, 1981 | K812670 | SANDARE FAST 340 PHOSPHORUS PROCEDURE Sandare Chemical Co., Inc. | CED |
| Sep 1, 1981 | K812313 | SANDARE URIC ACID PROCEDURE Sandare Chemical Co., Inc. | LFQ |
| Mar 4, 1981 | K810514 | SANDARE NITROPRUSSIDE TEST PROCEDURE Sandare Chemical Co., Inc. | JLC |
| Jan 16, 1981 | K802832 | SANDARE GLYCOHEMOGLOBIN PROCEDURE Sandare Chemical Co., Inc. | LCP |
| Jul 8, 1980 | K801422 | SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS. Sandare Chemical Co., Inc. | LCP |
| Apr 24, 1980 | K800780 | SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS Sandare Chemical Co., Inc. | JPK |
| Mar 5, 1980 | K800297 | SANDARE FAST 340 PHOSPHOROUS PROCEDURE Sandare Chemical Co., Inc. | CEO |
| Jan 11, 1980 | K792531 | SANDARE CHLORIDE PROCEDURE Sandare Chemical Co., Inc. | CHJ |
| Dec 31, 1979 | K792503 | SANDARE CYANMETHEMOGLOBIN REAGENT Sandare Chemical Co., Inc. | KHG |
| Dec 31, 1979 | K792358 | SANDARE CYANMETHEMOGLOBIN STANDARD Sandare Chemical Co., Inc. | KRZ |
| Dec 4, 1979 | K792209 | SANDARE HEMOGLOBIN CONTROLS Sandare Chemical Co., Inc. | JPK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||