510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Anaerobe Systems

Morgan Hill, CA, US

ANAEROBE SYSTEMS appears in FDA device records in Morgan Hill, CA. FDA records list 52 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
52
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

Showing 50 of 52

FDA records hold 52 510(k) clearances for Anaerobe Systems between 1978 and 1985. The busiest year on record is 1984, with 27. The most recent is 1985, with 4.

Clearances by year, as a table
510(k) clearance decisions for Anaerobe Systems, by decision year
YearClearances
19784
197917
198427
19854
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K844383KANAMYCIN 1000 MCG DIFFERENTIAL DISKJTOSubstantially Equivalent
K844382VANCOMYCIN 5MCG DIFFERENTIAL DISKJTOSubstantially Equivalent
K844381COLISTIN 10 MCG. DIFFERENTIAL DISKJTOSubstantially Equivalent
K844380BILE DIFFERENTIAL DISKJTOSubstantially Equivalent
K841303CAMPYLOBACTER THIOGLYCOLLATE MEDJSGSubstantially Equivalent
K841218CYCLOSERINE-CEFOXITIN FRUCTOSE AGARJSISubstantially Equivalent
K841142LEVINE EOSIN METHYLENE BLUE AGARJSISubstantially Equivalent
K841222BACTEROIDES BILE ESCULIN GARJSISubstantially Equivalent
K841221BRAIN HEART INFUSION BROTHJSCSubstantially Equivalent
K841220ANAEROBIC TRANSPORT MEDIUMJSLSubstantially Equivalent
K841219SHOPPED MEAT CARBOHYDRATEJSCSubstantially Equivalent
K841138MUELLER HINTON AGAR W/BLOOD & COFACTORJTZSubstantially Equivalent
K841144CHOCOLATE AGAR W/COFACTORJSGSubstantially Equivalent
K841143COLUMBIA AGAR W/5% SHEEP BLOODJSGSubstantially Equivalent
K841141MACCONKEY AGARJSISubstantially Equivalent
K841140PHENYLETHYL ALCOHOL BLOOD AGARJSJSubstantially Equivalent
K841139COLUMBIA AGAR W/COLISTIN, NALADIXICJSJSubstantially Equivalent
K841137MUELLER HINTON AGAR W/WO BLOODJTZSubstantially Equivalent
K841136SABOURAUD DEXTROSE AGAR W/CHLORAMPHEJSJSubstantially Equivalent
K841135MYCOSEL AGAR W/CHLORAMPHENICOL &JSJSubstantially Equivalent
K841134MANNITOL SALT AGARJSISubstantially Equivalent
K841133THAYER MARTIN MEDIUMJSJSubstantially Equivalent
K841132EILE-ESCULIN AZIDE AGARJSISubstantially Equivalent
K841131XYLOSE LYSINE DESOXYCHOLATE AGARJSISubstantially Equivalent
K841130TRYPTICASE SOY AGAR W/5% SHEEP BLOODJSGSubstantially Equivalent
K841129HEKTOEN ENTERIC AGARJSISubstantially Equivalent
K840031MICROBIAL DIFFERENTIATIONJTOSubstantially Equivalent
K840030REAGENTSJTOSubstantially Equivalent
K840029STRIPSJTOSubstantially Equivalent
K840028DISCSJTOSubstantially Equivalent
K834357ANA TRANS TUBE & SWABS STERILE PACKJSLSubstantially Equivalent
K791578CAMPYLOBACTER SELECTIVE MEDIUMJSJSubstantially Equivalent
K791579ANAEROBIC BRUCELLA BLOOD AGARJSISubstantially Equivalent
K791563ANAEROBIC BRUCELLA LAKED BLOOD AGARJSISubstantially Equivalent
K791562ANAEROBIC BRUCELLA BLOOD AGARJSGSubstantially Equivalent
K790627LOMBARD-DOWELL DEOXYRILBONUCLERIC ACIDJSHSubstantially Equivalent
K790625PEPTONE-YEAST EXTRACT BROTHJSCSubstantially Equivalent
K790628LOMBARD-DOWELL NECMYCIN EGG YOLK AGARJSISubstantially Equivalent
K790626LOMBARD-DOWELL GLUCOSE AGARJSFSubstantially Equivalent
K790624LOMBARD-DOWELL BROTH MEDIUM W/LACTATEJSISubstantially Equivalent
K790623LOMBARD-DOWELL MILK AGARJSHSubstantially Equivalent
K790622CHOPPED MEAT AGARJSGSubstantially Equivalent
K790621CHOPPED MEAT GLUCOSE MEDIUMJSGSubstantially Equivalent
K790620LOMBARD DOWELL BROTH MEDIUMW/TH REONINEJSCSubstantially Equivalent
K790619LOMBARD-DOWELL BROTH MEDIUMJSCSubstantially Equivalent
K790618LOMBARD-DOWELL STARCH AGARJSHSubstantially Equivalent
K790617CARBOHYDRATE FERMENTATION MEDIAJSESubstantially Equivalent
K790616ENRICHED THIOGLYCOLLATE MEDIUMJSCSubstantially Equivalent
K781856PLATE, LD PRESUMPTOJSESubstantially Equivalent
K781604CDC ANAEROBE BLOOD AGARJSGSubstantially Equivalent

Registered establishments

FDA registered establishments for Anaerobe Systems, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
29169322916932ANAEROBE SYSTEMS15906 CONCORD CIRCLE, MORGAN HILL, CA 95037 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

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.

What MDM checks, and what it does not

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 Anaerobe Systems edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain