510(k) K002199 ยท CFR Hexokinase, Glucose
MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Nov 20, 2000 |
| Received | Jul 20, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002199
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2008 | Pointe Scientific, Inc. Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG420-R1. (Clinical chemistry) Terminated |
CFR | None listed |
| Oct 31, 2008 | Pointe Scientific, Inc. Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG420-R2. (Clinical chemistry) Terminated |
CFR | None listed |
| Oct 31, 2008 | Pointe Scientific, Inc. Pointe Scientific Liquid Glucose HEX Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG720-600 and HG920-756. (Clinical chemistry) Terminated |
CFR | None listed |
| Oct 31, 2008 | Pointe Scientific, Inc. Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG920-1200, HG920-2500 and 12-HG920-144. (Clinical chemistry) Terminated |
CFR | None listed |
| Oct 31, 2008 | Pointe Scientific, Inc. Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry) Terminated |
CFR | None listed |
| Oct 31, 2008 | Pointe Scientific, Inc. Glucose HEX Reagent; HG920-SAM-911. (Clinical chemistry) Terminated |
CFR | None listed |
| Aug 3, 2006 | Pointe Scientific, Inc. Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, for the quantitative determination of glucose in serum, 5 x 600 ml R1 glucose HEX, for use with Hitachi analyzer; in vitro diagnostic, Catalog nu Terminated |
CFR | None listed |
| Aug 3, 2006 | Pointe Scientific, Inc. Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, for the quantitative determination of glucose in serum, 5 x 600 ml R2 glucose HEX, for use with Hitachi analyzer; in vitro diagnostic, Catalog nu Terminated |
CFR | None listed |
| Aug 3, 2006 | Pointe Scientific, Inc. Pointe Scientific Liquid Glucose (HEX) Reagent Set, for the quantitative determination of glucose in serum, 10 x 5 ml R1 and 5 x 20 ml R2, or 9 x 67 ml R1and 9 x 17 ml R2 glucose reagent, for use with Terminated |
CFR | None listed |
| Aug 3, 2006 | Pointe Scientific, Inc. Pointe Scientific Liquid Glucose (HEXO) Reagent Set, for the quantitative determination of glucose in serum, 10 x 100 ml R1, 10 x 20 ml R2 glucose reagent, or 1 x 2 L R1 x 500 ml R2, for use with Hita Terminated |
CFR | None listed |
| Aug 3, 2006 | Pointe Scientific, Inc. Glucose Hex reagent, sold by Pointe Scientific; in vitro diagnostic, Catalog no. 3-HG920-L . Terminated |
CFR | None listed |
| Aug 3, 2006 | Pointe Scientific, Inc. Glucose HEX reagent sold by Pointe Scientific; in vitro diagnostic, Catalog no. 3-HG920-L. Terminated |
CFR | None listed |
| Aug 3, 2006 | Pointe Scientific, Inc. Glucose HEX R1 reagent sold by Pointe Scientific; in vitro diagnostic, Catalog nos 3-HG920-R1, 7-HG920-R1-67, 7-HG920-R1-600 and 7-HG920-R1-800. Terminated |
CFR | None listed |
| Aug 3, 2006 | Pointe Scientific, Inc. Glucose HEX R2 reagent sold by Pointe Scientific; in vitro diagnostic, Catalog nos 3-HG920-R2, 7-HG920-R2-17, 7-HG920-R2-200 and 7-HG920-R2-300. Terminated |
CFR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.