# Pointe Scientific, Inc.,

- Location (FDA's records): Lincoln Park, MI
- FDA decisions: 74 (1981–2007): 74 510(k) clearances
- Product codes: LCP (4), CFR (4), JFJ (4), CIG (4), CDT (3), CIC (3), KHS (3), CFJ (3), LBR (3), CGA (2), CKA (2), CIT (2)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 81 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostic Systems, Inc.: 1 (https://510kreport.com/company/roche-diagnostic-systems)

## Firms that cite its devices most
- Baebies, Inc.: 1 (https://510kreport.com/company/baebies)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Taidoc Technology Corporation: 1 (https://510kreport.com/company/taidoc-technology)
- Teco Diagnostics: 1 (https://510kreport.com/company/teco-diagnostics)
- Elitechgroup: 1 (https://510kreport.com/company/elitechgroup)
- Seppim S.A.S.: 1 (https://510kreport.com/company/seppim)

## Its most-cited devices
- K031539: Hemoglobin A1C Reagent Set (2003), cited by 2
- K921625: Calcium-Arsenazo Iii Reagent Set (1992), cited by 1
- K024006: G6PDH, Glucose-6-Phoshate Dehydrogenase (2003), cited by 1
- K070251: Carbon Dioxide Liquid Stable Reagent (2007), cited by 1
- K002199: Modification to Liquid Glucose (Hexokinase) Reagent Set (2000), cited by 1

## Recent decisions
- K070757: Microprotein Reagent Set (Dec 4, 2007)
- K062118: Pointe 360 (Jul 13, 2007)
- K070251: Carbon Dioxide Liquid Stable Reagent (Apr 30, 2007)
- K070207: Multi-Analyte Chemistry Calibrator (Apr 13, 2007)
- K070504: Ammonia/Alcohol Control Set (Apr 11, 2007)
- K061377: Apolipoprotein A1 and Apolipoprotein B Reagents and Calibrators (Mar 28, 2007)
- K051646: Ise Diluent, 1N KCL, Internal Reference and Ise Standards Low and High (Oct 7, 2005)
- K040391: Total Bilirubin Reagent Set (Jun 2, 2004)

Source page: https://510kreport.com/company/pointe-scientific