Company ยท US
Hillcrest Biologicals
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1992. Name variants (Inc, Corp, punctuation) are merged.
33510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | 4 |
| GNK | Antisera, Cf, Echovirus 1-34 | 3 |
| JSM | Culture Media, Non-Propagating Transport | 3 |
| GNL | Antigens, Cf (Including Cf Control), Echovirus 1-34 | 2 |
| GPJ | Antiserum, Fluorescent, Q Fever | 2 |
| GQC | Antisera, Cf, Equine Encephalitis Virus, Eee, Wee | 2 |
| GNG | Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6 | 1 |
| GNO | Antisera, Cf, Coxsackievirus A 1-24, B 1-6 | 1 |
| GNP | Antiserum, Cf, Epstein-Barr Virus | 1 |
| GOG | Antisera, Cf, Poliovirus 1-3 | 1 |
| GPN | Antiserum, Typhus Fever | 1 |
| GPW | Antigen, Cf, Psittacosis (Chlamydia Group) | 1 |
| GQI | Antiserum, Cf, Cytomegalovirus | 1 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 1 |
| GRY | Antigens, All, Leptospira Spp. | 1 |
| GSB | Antigens, Cf, All, Mycoplasma Spp. | 1 |
| JRY | Antiserum, Fluorescent, Epstein-Barr Virus | 1 |
| KHW | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. | 1 |
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 1 |
| KLC | Chair, Dental, With Operative Unit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 3, 1992 | K913618 | ARBOVIRUS IGM IFA TEST Hillcrest Biologicals | GQC |
| Dec 3, 1992 | K913617 | ARBOVIRUS IGG IFA TEST Hillcrest Biologicals | GQC |
| Oct 21, 1992 | K922374 | Q FEVER IGM IFA TEST Hillcrest Biologicals | GPJ |
| Oct 21, 1992 | K913906 | Q FEVER IGG IFA TEST Hillcrest Biologicals | GPJ |
| Jun 28, 1991 | K900206 | LYME DISEASE IGM ELISA Hillcrest Biologicals | LSR |
| Jan 16, 1990 | K896594 | EBV VCA ANTIBODY (IGM) Hillcrest Biologicals | LJN |
| Apr 12, 1989 | K884829 | EBV EARLY ANTIGEN (R+D) Hillcrest Biologicals | JRY |
| Mar 15, 1989 | K883767 | LYME DISEASE IFA (IGM) Hillcrest Biologicals | LSR |
| Jan 24, 1989 | K884591 | EBV-VCA ANTIBODY (IGG) Hillcrest Biologicals | GNP |
| Dec 13, 1988 | K883487 | LYME DISEASE IFA (IGG) Hillcrest Biologicals | LSR |
| May 23, 1988 | K875170 | EBNA ANTIBODY Hillcrest Biologicals | LLM |
| Apr 26, 1988 | K880476 | LYME DISEASE ELISA Hillcrest Biologicals | LSR |
| Apr 12, 1988 | K880417 | LEPTOSPIROSIS IHA Hillcrest Biologicals | GRY |
| Mar 12, 1987 | K864110 | RICKETTSIAL IGG AND IGM IFA KIT Hillcrest Biologicals | GPN |
| Dec 23, 1985 | K854715 | TRANSPORT CULTURE MEDIA Hillcrest Biologicals | JSM |
| Nov 7, 1985 | K853279 | COXSACKIE A2 CF ANTIGEN, A4, A10 & A16 Hillcrest Biologicals | GNO |
| Nov 7, 1985 | K853278 | POLIO TYPE I CF ANTIGEN, & TYPE II, III Hillcrest Biologicals | GOG |
| Nov 7, 1985 | K853277 | CMV CF ANTIGEN Hillcrest Biologicals | GQI |
| Nov 7, 1985 | K853165 | ECHO TYPE 30 CF ANTIGEN Hillcrest Biologicals | GNK |
| Nov 7, 1985 | K853157 | ECHO TYPE 11 CF ANTIGEN Hillcrest Biologicals | GNK |
| Nov 7, 1985 | K853156 | ECHO TYPE 16 CF ANTIGEN Hillcrest Biologicals | GNK |
| Sep 16, 1985 | K852494 | CMV-IHA Hillcrest Biologicals | LJO |
| Aug 28, 1985 | K853448 | HILLCREST AMEBIASIS IHA TEST Hillcrest Biologicals | KHW |
| May 9, 1985 | K850609 | HERPES SIMPLEX GROUP CF ANTIGEN Hillcrest Biologicals | GQN |
| Mar 20, 1985 | K850537 | CELL CULTURE REFEED MEDIUM Hillcrest Biologicals | KIT |
| Mar 5, 1985 | K850003 | COXSACKIE B SERIES CF ANTIGENS Hillcrest Biologicals | GNG |
| Mar 5, 1985 | K844967 | ECHO TYPE 9 CF ANTIGEN Hillcrest Biologicals | GNL |
| Mar 5, 1985 | K844868 | CHLAMYDIA GROUP CF ANTIGEN Hillcrest Biologicals | GPW |
| Mar 5, 1985 | K844695 | ECHO TYPE 4 CF ANTIGEN Hillcrest Biologicals | GNL |
| Mar 4, 1985 | K850124 | CHLAMYDIAL TRANSPORT MEDIA Hillcrest Biologicals | JSM |
| Jan 4, 1985 | K844747 | VIRAL TRANSPORT MEDIA Hillcrest Biologicals | JSM |
| Feb 27, 1984 | K834338 | MYCOPLASMA PNEUMONIAE CF ANTIGEN Hillcrest Biologicals | GSB |
| Apr 5, 1983 | K822095 | HERPES-IHA KIT Hillcrest Biologicals | KLC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||