Hillcrest Biologicals
Mchenry, IL, US
Hillcrest Biologicals appears in FDA device records in Mchenry, IL. FDA records list 33 510(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
- 33
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 33 510(k) clearances for Hillcrest Biologicals between 1983 and 1992. The busiest year on record is 1985, with 17. The most recent is 1992, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 17 |
| 1987 | 1 |
| 1988 | 4 |
| 1989 | 3 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K913618 | ARBOVIRUS IGM IFA TEST | GQC | Substantially Equivalent | |
| K913617 | ARBOVIRUS IGG IFA TEST | GQC | Substantially Equivalent | |
| K922374 | Q FEVER IGM IFA TEST | GPJ | Substantially Equivalent | |
| K913906 | Q FEVER IGG IFA TEST | GPJ | Substantially Equivalent | |
| K900206 | LYME DISEASE IGM ELISA | LSR | Substantially Equivalent | |
| K896594 | EBV VCA ANTIBODY (IGM) | LJN | Substantially Equivalent | |
| K884829 | EBV EARLY ANTIGEN (R+D) | JRY | Substantially Equivalent | |
| K883767 | LYME DISEASE IFA (IGM) | LSR | Substantially Equivalent | |
| K884591 | EBV-VCA ANTIBODY (IGG) | GNP | Substantially Equivalent | |
| K883487 | LYME DISEASE IFA (IGG) | LSR | Substantially Equivalent | |
| K875170 | EBNA ANTIBODY | LLM | Substantially Equivalent | |
| K880476 | LYME DISEASE ELISA | LSR | Substantially Equivalent | |
| K880417 | LEPTOSPIROSIS IHA | GRY | Substantially Equivalent | |
| K864110 | RICKETTSIAL IGG AND IGM IFA KIT | GPN | Substantially Equivalent | |
| K854715 | TRANSPORT CULTURE MEDIA | JSM | Substantially Equivalent | |
| K853279 | COXSACKIE A2 CF ANTIGEN, A4, A10 & A16 | GNO | Substantially Equivalent | |
| K853278 | POLIO TYPE I CF ANTIGEN, & TYPE II, III | GOG | Substantially Equivalent | |
| K853277 | CMV CF ANTIGEN | GQI | Substantially Equivalent | |
| K853165 | ECHO TYPE 30 CF ANTIGEN | GNK | Substantially Equivalent | |
| K853157 | ECHO TYPE 11 CF ANTIGEN | GNK | Substantially Equivalent | |
| K853156 | ECHO TYPE 16 CF ANTIGEN | GNK | Substantially Equivalent | |
| K852494 | CMV-IHA | LJO | Substantially Equivalent | |
| K853448 | HILLCREST AMEBIASIS IHA TEST | KHW | Substantially Equivalent | |
| K850609 | HERPES SIMPLEX GROUP CF ANTIGEN | GQN | Substantially Equivalent | |
| K850537 | CELL CULTURE REFEED MEDIUM | KIT | Substantially Equivalent | |
| K850003 | COXSACKIE B SERIES CF ANTIGENS | GNG | Substantially Equivalent | |
| K844967 | ECHO TYPE 9 CF ANTIGEN | GNL | Substantially Equivalent | |
| K844868 | CHLAMYDIA GROUP CF ANTIGEN | GPW | Substantially Equivalent | |
| K844695 | ECHO TYPE 4 CF ANTIGEN | GNL | Substantially Equivalent | |
| K850124 | CHLAMYDIAL TRANSPORT MEDIA | JSM | Substantially Equivalent | |
| K844747 | VIRAL TRANSPORT MEDIA | JSM | Substantially Equivalent | |
| K834338 | MYCOPLASMA PNEUMONIAE CF ANTIGEN | GSB | Substantially Equivalent | |
| K822095 | HERPES-IHA KIT | KLC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LJNAntibody Igm, If, Epstein-Barr Virus
- GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- GPWAntigen, Cf, Psittacosis (Chlamydia Group)
- KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
- LJOAntigen, Iha, Cytomegalovirus
- GRYAntigens, All, Leptospira Spp.
- GNGAntigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6
- GNLAntigens, Cf (Including Cf Control), Echovirus 1-34
- GSBAntigens, Cf, All, Mycoplasma Spp.
- GNOAntisera, Cf, Coxsackievirus A 1-24, B 1-6
- GNKAntisera, Cf, Echovirus 1-34
- GQCAntisera, Cf, Equine Encephalitis Virus, Eee, Wee
- GOGAntisera, Cf, Poliovirus 1-3
- GQIAntiserum, Cf, Cytomegalovirus
- GNPAntiserum, Cf, Epstein-Barr Virus
- JRYAntiserum, Fluorescent, Epstein-Barr Virus
- GPJAntiserum, Fluorescent, Q Fever
- GPNAntiserum, Typhus Fever
- KLCChair, Dental, With Operative Unit
- JSMCulture Media, Non-Propagating Transport
- KITMedia And Components, Synthetic Cell And Tissue Culture
- LSRReagent, Borrelia Serological Reagent
- LLMTest, Antigen, Nuclear, Epstein-Barr Virus
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.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Hillcrest Biologicals edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Hillcrest Biologicals. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain