510(k) K973588 ยท CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
LIQUID ALKALINE PHOSHATASE REAGENT SET
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Oct 22, 1997 |
| Received | Sep 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973588
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2008 | Pointe Scientific, Inc. Liquid Alkaline Phosphatase Reagent Set, Catalog Nos. A7516-150, A7516-450, A7516-625, HA916-302 and HA916-492, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum Terminated |
CJE | None listed |
| Mar 27, 2008 | Pointe Scientific, Inc. Liquid Alkaline Phosphatase (R2) Reagent Set, Catalog No.: H A416-R2, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc Terminated |
CJE | None listed |
| Mar 27, 2008 | Pointe Scientific, Inc. Liquid Alk Phos Reagent, Catalog No. 3-A7516-L, In vitro diagnostic, Sold by Pointe Scientific. Terminated |
CJE | None listed |
| Mar 27, 2008 | Pointe Scientific, Inc. Liquid Alk Phos R1 Reagent, Catalog No. 3-A7516-R1, In vitro diagnostic, Sold by Pointe Scientific. Terminated |
CJE | None listed |
| Mar 27, 2008 | Pointe Scientific, Inc. Liquid Alk Phos R2 Reagent, Catalog No. 3-A7516-R2, In vitro diagnostic, Sold by Pointe Scientific Terminated |
CJE | None listed |
| Mar 27, 2008 | Pointe Scientific, Inc. Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent, Catalog Nos. 7-A7516-R1-120, 7-A7516-R1-500 and 8-A7516-R1-120, In vitro diagnostic, 50 mL, 120 mL , 2 L and 500 mL containers, Sold by Terminated |
CJE | None listed |
| Mar 27, 2008 | Pointe Scientific, Inc. Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent; Catalog Nos. 7-A7516-R2-125, 7-A7516-R2-90 and 8-A7516-R2-30, In vitro diagnostic, 30 mL, 90 mL , 125 mL, and 400 mL containers, Sold b Terminated |
CJE | None listed |
| Mar 27, 2008 | Pointe Scientific, Inc. Liquid Alkaline Phosphatase Reagent Set; Catalog No. A7516-150-SAM, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum, Sold by Pointe Scientific, Inc Terminated |
CJE | None listed |
| Aug 10, 2006 | Pointe Scientific, Inc. Liquid Alkaline Phosphatase Reagent Set for the quantitative determination of alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc.; Catalog nos. A7516-150, A7516-450, A7516-625, HA7 Terminated |
CJE | None listed |
| Aug 10, 2006 | Pointe Scientific, Inc. Liquid Alkaline Phosphatase (R1) Reagent Set for the quantitative determination of alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc.; Catalog no. H A416-R1. In vitro diagnostic. Terminated |
CJE | None listed |
| Aug 10, 2006 | Pointe Scientific, Inc. Liquid Alkaline Phosphatase (R2) Reagent Set for the quantitative determination of alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc.; Catalog no. H A416-R2. In vitro diagnostic. Terminated |
CJE | None listed |
| Aug 10, 2006 | Pointe Scientific, Inc. Alkaline Phosphatase Buffer Mfg. for Alfa Wassermann Diagnostic Technologies LLC, Caldwell, N.J. in 8.4 mL and 30 mL containers. In vitro diagnostic. Terminated |
CJE | None listed |
| Aug 10, 2006 | Pointe Scientific, Inc. Alkaline Phosphatase Substrate Mfg. for Alfa Wassermann Diagnostic Technologies LLC, Caldwell, N.J. in 2.1 mL and 7.5mL containers. In vitro diagnostic. Terminated |
CJE | None listed |
| Aug 10, 2006 | Pointe Scientific, Inc. Liquid Alk Phos Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-L. In vitro diagnostic. Terminated |
CJE | None listed |
| Aug 10, 2006 | Pointe Scientific, Inc. Liquid Alk Phos R1 Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-R1. In vitro diagnostic. Terminated |
CJE | None listed |
| Aug 10, 2006 | Pointe Scientific, Inc. Liquid Alk Phos R2 Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-R2. In vitro diagnostic. Terminated |
CJE | None listed |
| Aug 10, 2006 | Pointe Scientific, Inc. Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent in 50 ml, 120 ml, 2 L and 500 ml containers, sold by Pointe Scientific; Catalog nos. 7-HA716-R1-50-917, 7-A7516-R1-120, 7-A7516-R1-2L, 7-A Terminated |
CJE | None listed |
| Aug 10, 2006 | Pointe Scientific, Inc. Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent in 30 ml, 90 ml, 125 ml and 400 ml containers, sold by Pointe Scientific; Catalog nos. 7-A7516-R2-125, 7-A7516-R2-30, 7-A7516-R2-400ML, 7- Terminated |
CJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.