North American Science Assoc., Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “North American Science Assoc., Inc.” (first 1997, latest 2014), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 192 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 126 |
| 2013 | 0 | — |
| 2014 | 2 | 210 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | 3 | 3 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 2 | 2 |
| MTC | Indicator, Chemical, Enzymatic, Sterilization Process | 1 | 1 |
Review panels
- General Hospital (6)
Most recent North American Science Assoc., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141244 | NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES) | FRC | 2014-09-09 | 118 |
| K132291 | NAMSA CHEMICAL PROCESS | JOJ | 2014-05-20 | 301 |
| K113221 | NAMSA BIOLOGICAL INDICATOR SPORE STRIPS | FRC | 2012-04-27 | 178 |
| K113302 | NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS | FRC | 2012-01-20 | 73 |
| K983451 | CHALLENGE TEST PACK | JOJ | 1999-04-23 | 205 |
| K962649 | SPORTROL RAPID STERILITY INDICATOR | MTC | 1997-09-26 | 445 |
Recalls
openFDA lists no recalls under a recalling firm named North American Science Assoc., Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- North American Instrument Corp. (28 510(k)s)
- North American Sterilization & Packaging Co. (16 510(k)s)
- North American Philips Corp. (15 510(k)s)
- North Pacific Dental, Inc. (11 510(k)s)
- North East Monitoring, Inc. (10 510(k)s)
- North American Technical Services Corp. (9 510(k)s)
- North American Biologicals, Inc. (6 510(k)s)
- North American Medical Products, Inc. (6 510(k)s)
- North Coast Medi-Tek (6 510(k)s)
- North American Alloys, Inc. (5 510(k)s)
- North American Scientific, Inc. (4 510(k)s)
- North American Medical Corp (Nam) (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under North American Science Assoc., Inc.?
FDA lists 6 510(k) clearances under the applicant name “North American Science Assoc., Inc.” (first 1997, latest 2014), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by North American Science Assoc., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name North American Science Assoc., Inc. is 192 days.
Which FDA product codes appear under North American Science Assoc., Inc.?
The most frequent FDA product codes under this applicant name are FRC (Indicator, Biological Sterilization Process, 3); JOJ (Indicator, Physical/Chemical Sterilization Process, 2); MTC (Indicator, Chemical, Enzymatic, Sterilization Process, 1).
Next steps
- See all 6 North American Science Assoc., Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRC, North American Science Assoc., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.