American Scientific Products
Mchenry, IL, US
American Scientific Products appears in FDA device records in Mchenry, IL. FDA records list 28 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 28
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 28 510(k) clearances for American Scientific Products between 1981 and 1986. The busiest year on record is 1981, with 11. The most recent is 1986, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 11 |
| 1982 | 7 |
| 1983 | 8 |
| 1984 | 1 |
| 1986 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K864824 | INFECTIOUS TISSUE KIT | Substantially Equivalent | ||
| K844042 | BLOOD DILUTION VIAL | GKL | Substantially Equivalent | |
| K831634 | GLUCOSE REAGENT B6360-11 | CGA | Substantially Equivalent | |
| K831626 | UREA NITROGEN-BUN-REAGENTS B6370-11A | CDQ | Substantially Equivalent | |
| K831625 | UREA NITROGEN-BUN-REAGENTS B6360-12 | CDQ | Substantially Equivalent | |
| K831628 | CREATININE REAGENTS B6370-13 | CGX | Substantially Equivalent | |
| K831627 | CREATININE REAGENTS B6360-10 | CGX | Substantially Equivalent | |
| K831624 | GLUCOSE REAGENT KITS-B6370-10A | CGA | Substantially Equivalent | |
| K831571 | ROTOR | JJG | Substantially Equivalent | |
| K831569 | REAGENT CUPS | JJG | Substantially Equivalent | |
| K822799 | STREPTACOCCUS CO-AGGLUTINATION KIT | GTP | Substantially Equivalent | |
| K822988 | COAGULASE PLASMA-CITRATED & EDTA | JTL | Substantially Equivalent | |
| K822870 | STOOL-COLLECTION/PRESERVATION KIT | KDT | Substantially Equivalent | |
| K821660 | BIO-CHECK GRAM STAIN CONTROL | JTR | Substantially Equivalent | |
| K820683 | STAPHYLOCOCCUS LATEX AGGLUTINATION KIT | LHT | Substantially Equivalent | |
| K820533 | B4182-1 | GIE | Substantially Equivalent | |
| K820532 | DISPO FIBRIN PIPET TIPS B4182-2 | GIE | Substantially Equivalent | |
| K813359 | MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL | GMJ | Substantially Equivalent | |
| K812194 | IMMUNODIFFUSION BAND INTENSIFYING FLUID | JZS | Substantially Equivalent | |
| K812193 | KOH MOUNTING FLUID | LEB | Substantially Equivalent | |
| K812192 | LACTO-PHENOL ANILINE BLUE MOUNTING FLUID | LED | Substantially Equivalent | |
| K812191 | VASPAR SEALENT | KEO | Substantially Equivalent | |
| K812190 | COCCIDIOIDES IMMUNODIFFUSION SYSTEM | GMI | Substantially Equivalent | |
| K812188 | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI | GMD | Substantially Equivalent | |
| K812187 | SMITH'S SYSTEMIC FUNGAL MEDIUM | JSI | Substantially Equivalent | |
| K812189 | COCCIDIOIDES LATEX AGGLUTINATION | GMG | Substantially Equivalent | |
| K812186 | CANDIDA IMMUNODIFFUSION SYSTEM | LHK | Substantially Equivalent | |
| K812185 | FUNGAL IMMUNODIFFUSION SYSTEM | GMI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJGAnalyzer, Chemistry, Centrifugal, For Clinical Use
- GMIAntigen, Cf And / Or Id, Coccidioides Immitis
- LHKAntigen, Id, Candida Albicans
- GMGAntigen, Latex Agglutination, Coccidioides Immitis
- GMJAntigens, Histoplasma Capsulatum, All
- GMDAntisera, Latex Agglutination, Cryptococcus Neoformans
- KDTContainer, Specimen Mailer And Storage, Sterile
- GKLCounter, Cell, Automated (Particle Counter)
- JSICulture Media, Selective And Differential
- JZSElectrophoresis Instrumentation
- GTPExoenzymes, Multiple, Streptococcal
- GIEFibrometer
- KEOFormulations, Paraffin, All
- CGAGlucose Oxidase, Glucose
- JTRKit, Quality Control For Culture Media
- LEBMounting Media
- JTLPlasma, Coagulase, Human, Horse And Rabbit
- LEDStains, Chemical Solution
- LHTStaphylococcus Aureus Somatic Antigens
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain