North American Biologicals, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “North American Biologicals, Inc.” (first 1978, latest 1982), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 44 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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 |
|---|---|---|---|
| KSX | Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use | 3 | 3 |
| KSD | Device, Heat-Sealing | 1 | 1 |
| KSF | Kit, Quality Control For Blood Banking Reagents | 1 | 1 |
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | 1 | 1 |
Review panels
- Hematology (6)
Most recent North American Biologicals, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K820301 | PLASMA POOLER HEAT SEALER | KSD | 1982-04-09 | 64 |
| K801219 | PLASMAPOOLER | KSR | 1980-10-31 | 163 |
| K801425 | RH CONTROL | KSF | 1980-07-14 | 27 |
| K781896 | BLOOD GROUP SUBSTANCE A,B | KSX | 1978-12-20 | 44 |
| K781895 | BLOOD GROUP SUBSTANCE B | KSX | 1978-12-20 | 44 |
| K781862 | BLOOD GROUP SUBSTANCE A | KSX | 1978-12-20 | 44 |
Recalls
openFDA lists no recalls under a recalling firm named North American Biologicals, 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 Medical Products, Inc. (6 510(k)s)
- North American Science Assoc., 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 Eos Industries, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under North American Biologicals, Inc.?
FDA lists 6 510(k) clearances under the applicant name “North American Biologicals, Inc.” (first 1978, latest 1982), across 4 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 Biologicals, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name North American Biologicals, Inc. is 44 days.
Which FDA product codes appear under North American Biologicals, Inc.?
The most frequent FDA product codes under this applicant name are KSX (Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use, 3); KSD (Device, Heat-Sealing, 1); KSF (Kit, Quality Control For Blood Banking Reagents, 1).
Next steps
- See all 6 North American Biologicals, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KSX, North American Biologicals, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.